<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02978326</url>
  </required_header>
  <id_info>
    <org_study_id>217-PPD-201</org_study_id>
    <nct_id>NCT02978326</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression</brief_title>
  <official_title>A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sage Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sage Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study was to determine if treatment with SAGE-217 reduces&#xD;
      depressive symptoms in participants with severe postpartum depression (PPD) compared to&#xD;
      placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for&#xD;
      Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of&#xD;
      SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign&#xD;
      measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the&#xD;
      Columbia Suicide Severity Rating Scale (C-SSRS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15</measure>
    <time_frame>Parts A and B: Baseline, Day 15</time_frame>
    <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45</measure>
    <time_frame>Part B: Baseline, Days 3, 8, 21 and 45</time_frame>
    <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Percentage of Participants With HAM-D Response</measure>
    <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
    <description>HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Percentage of Participants With HAM-D Remission</measure>
    <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
    <description>HAM-D Remission was defined as a HAM-D total score of less than or equal to (&lt;=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Change From Baseline in HAM-D Subscales Scores</measure>
    <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
    <description>HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety [psychic and somatic], somatic symptoms [gastrointestinal and general], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Change From Baseline in HAM-D Individual Item Scores</measure>
    <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
    <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score</measure>
    <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
    <description>The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response</measure>
    <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
    <description>The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score</measure>
    <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
    <description>The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of &lt;17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Percentage of Participants With MADRS Response</measure>
    <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
    <description>MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Percentage of Participants With MADRS Remission</measure>
    <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
    <description>MADRS Remission was defined as a MADRS total score of &lt;=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Part A: Up to Day 75; Part B: Up to Day 45</time_frame>
    <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements</measure>
    <time_frame>Part B: From first dose of study drug up to 45 days</time_frame>
    <description>Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations</measure>
    <time_frame>Part B: From first dose of study drug up to 45 days</time_frame>
    <description>Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate</measure>
    <time_frame>Part B: Baseline, Days 8, 15, and 21</time_frame>
    <description>ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval</measure>
    <time_frame>Part B: Baseline, Days 8, 15, and 21</time_frame>
    <description>ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part B: Number of Participants With a Response of &quot;Yes&quot; to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Part B: Up to Day 45</time_frame>
    <description>C-SSRS was used to assess the suicidality of participants during the study. The assessment included &quot;yes&quot; or &quot;no&quot; responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">276</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>Part A: SAGE-217 15/20 mg Oral Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: SAGE 217 30 mg Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE-217 15/20 mg Oral Solution</intervention_name>
    <description>SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).</description>
    <arm_group_label>Part A: SAGE-217 15/20 mg Oral Solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
    <arm_group_label>Part B: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAGE 217 30 mg Capsules</intervention_name>
    <description>SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
    <arm_group_label>Part B: SAGE 217 30 mg Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Participant either must have ceased lactating at screening or, if still lactating or&#xD;
             actively breastfeeding at screening, must agree to temporarily cease giving breast&#xD;
             milk to her infant(s)&#xD;
&#xD;
          -  Participant has had a Major Depressive Episode that began no earlier than the third&#xD;
             trimester and no later than the first 4 weeks following delivery, as diagnosed by the&#xD;
             Structured Clinical Interview for Diagnostic and Statistical Manual of Mental&#xD;
             Disorders (DSM)-5 Axis I Disorders (SCID-I)&#xD;
&#xD;
          -  Participant was &lt;=six months postpartum.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Attempted suicide associated with current episode of postpartum depression&#xD;
&#xD;
          -  Medical history of seizures&#xD;
&#xD;
          -  Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.&#xD;
&#xD;
        Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion&#xD;
        criteria might apply.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <zip>92595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational SIte</name>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33782</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Hoffman Estates</city>
        <state>Illinois</state>
        <zip>60169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Owensboro</city>
        <state>Kentucky</state>
        <zip>42303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sage Investigational Site</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sagerx.com</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Deligiannidis K, Lasser R, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Assessment of Depressive Symptoms Across Multiple Measures. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.</citation>
  </results_reference>
  <results_reference>
    <citation>Lasser R, Deligiannidis K, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Topline Assessment of Secondary Efficacy Measures of Anxiety and Depression. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.</citation>
  </results_reference>
  <results_reference>
    <citation>Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559. Erratum In: JAMA Psychiatry. 2022 Jul 1;79(7):740. JAMA Psychiatry. 2023 Feb 1;80(2):191.</citation>
    <PMID>34190962</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <results_first_submitted>November 15, 2021</results_first_submitted>
  <results_first_submitted_qc>November 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 16, 2021</results_first_posted>
  <disposition_first_submitted>November 15, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>November 15, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 20, 2019</disposition_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postpartum Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02978326/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02978326/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 27 investigative centers in the United States of America from 04 January 2017 to 11 December 2018. Study was conducted in 2 parts. In Part A, only 1 participant was enrolled and thus no analysis was performed for Part A. All analysis sets were defined only for Part B. For Part A, only adverse events incidence were captured.</recruitment_details>
      <pre_assignment_details>A total of 276 participants were enrolled and consented of which 154 eligible participants were randomized and thus presented in participant flow. Rest of the 123 participants were not randomized and not part of any analyses. 152 randomized participants received study drug and 143 completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
          <description>Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
        </group>
        <group group_id="P2">
          <title>Part B: Placebo</title>
          <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
        </group>
        <group group_id="P3">
          <title>Part B: SAGE 217 30 mg Capsules</title>
          <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part A (Up to 75 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part B (Up to 45 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="76"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="78">Two participants were randomized to placebo but received at least 1 dose of SAGE-217 in error and were included in the SAGE-217 group for 'Received Study Drug' and for 'Safety Analysis'.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Set (Part B)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="73"/>
                <participants group_id="P3" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Efficacy Set (Part B)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="76"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="69"/>
                <participants group_id="P3" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Part A: All randomized participants; Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
          <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
        </group>
        <group group_id="B2">
          <title>Part B: Placebo</title>
          <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Part B: SAGE 217 30 mg Capsules</title>
          <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="76"/>
            <count group_id="B4" value="151"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Due to the low number of participants enrolled during Part A of the study, 0 participants are reported due to the risk of identification of a person.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>Due to the low number of participants enrolled during Part A of the study, 0 participants are reported due to the risk of identification of a person.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="44"/>
                    <measurement group_id="B4" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score</title>
          <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. HAM-D total score=sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="28.8" lower_limit="26" upper_limit="40"/>
                    <measurement group_id="B3" value="28.4" lower_limit="26" upper_limit="34"/>
                    <measurement group_id="B4" value="28.6" lower_limit="26" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HAM-D Subscales Scores</title>
          <description>HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale; Anxiety subscale; Bech-6 subscale; Meier subscale. Each item in the subscale was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicating more severe depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Core</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="50.1" lower_limit="40" upper_limit="80"/>
                    <measurement group_id="B3" value="51.3" lower_limit="40" upper_limit="70"/>
                    <measurement group_id="B4" value="50.7" lower_limit="40" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="56.3" lower_limit="28" upper_limit="78"/>
                    <measurement group_id="B3" value="53.1" lower_limit="39" upper_limit="78"/>
                    <measurement group_id="B4" value="54.7" lower_limit="28" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bech-6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="64.5" lower_limit="50" upper_limit="86"/>
                    <measurement group_id="B3" value="66.3" lower_limit="50" upper_limit="82"/>
                    <measurement group_id="B4" value="65.4" lower_limit="50" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meier</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="57.1" lower_limit="46" upper_limit="79"/>
                    <measurement group_id="B3" value="59.1" lower_limit="42" upper_limit="83"/>
                    <measurement group_id="B4" value="58.1" lower_limit="42" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HAM-D Individual Item Scores</title>
          <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Symptoms scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Depressed Mood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="3.1" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B3" value="3.1" lower_limit="3" upper_limit="4"/>
                    <measurement group_id="B4" value="3.1" lower_limit="2" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings of Guilt</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="2.2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B3" value="2.5" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="B4" value="2.35" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.4" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="0.4" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="0.4" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early - Early Night</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.8" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B3" value="1.8" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="1.8" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Middle - Middle Night</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.9" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B3" value="1.7" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="1.8" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early Hours - Morning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.5" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B3" value="1.6" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="1.55" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and Activities</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="3.1" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="B3" value="3.0" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B4" value="3.05" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retardation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="1.2" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B4" value="1.2" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.4" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="1.4" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="B4" value="1.4" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Psychic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="2.7" lower_limit="2" upper_limit="4"/>
                    <measurement group_id="B3" value="2.9" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="B4" value="2.8" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Somatic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.9" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="1.9" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B4" value="1.9" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somatic Symptoms Gastrointestinal</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.5" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B3" value="1.3" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="1.4" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Somatic Symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.8" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B3" value="1.8" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="1.8" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital Symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.9" lower_limit="1" upper_limit="2"/>
                    <measurement group_id="B3" value="1.9" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="1.9" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypochondriasis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="1.3" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B3" value="1.0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="B4" value="1.15" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Weight According to Patient</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.9" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B3" value="0.6" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="B4" value="0.75" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insight</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="0.1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B3" value="0.1" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="B4" value="0.1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score</title>
          <description>The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). MADRS total score was calculated as sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="36.3" lower_limit="27" upper_limit="50"/>
                    <measurement group_id="B3" value="34.9" lower_limit="26" upper_limit="45"/>
                    <measurement group_id="B4" value="35.6" lower_limit="26" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hamilton Anxiety Rating Scale (HAM-A) Total Score</title>
          <description>The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of &lt;17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="76"/>
                    <count group_id="B4" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="27.2" lower_limit="17" upper_limit="40"/>
                    <measurement group_id="B3" value="26.1" lower_limit="14" upper_limit="40"/>
                    <measurement group_id="B4" value="26.65" lower_limit="14" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15</title>
        <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
        <time_frame>Parts A and B: Baseline, Day 15</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15</title>
          <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.6" spread="1.07"/>
                    <measurement group_id="O3" value="-17.8" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0028</p_value>
            <p_value_desc>Mixed Model for Repeated Measures (MMRM) was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>Least Squares (LS) Mean Difference</param_type>
            <param_value>-4.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.9</ci_lower_limit>
            <ci_upper_limit>-1.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45</title>
        <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
        <time_frame>Part B: Baseline, Days 3, 8, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45</title>
          <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-9.8" spread="0.95"/>
                    <measurement group_id="O3" value="-12.5" spread="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-12.9" spread="1.03"/>
                    <measurement group_id="O3" value="-16.3" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-14.4" spread="1.11"/>
                    <measurement group_id="O3" value="-17.6" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-15.1" spread="1.06"/>
                    <measurement group_id="O3" value="-19.2" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in the HAM-D Total Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0252</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.1</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in the HAM-D Total Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0106</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in the HAM-D Total Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0321</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.0</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in the HAM-D Total Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0027</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.7</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Percentage of Participants With HAM-D Response</title>
        <description>HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.</description>
        <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Percentage of Participants With HAM-D Response</title>
          <description>HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="27.0"/>
                    <measurement group_id="O3" value="40.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="44.6"/>
                    <measurement group_id="O3" value="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="47.9"/>
                    <measurement group_id="O3" value="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="56.2"/>
                    <measurement group_id="O3" value="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="56.5"/>
                    <measurement group_id="O3" value="75.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Response at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1004</p_value>
            <p_value_desc>Generalized estimating equations (GEE) for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>3.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Response at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0127</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.20</ci_lower_limit>
            <ci_upper_limit>4.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Response at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0049</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.34</ci_lower_limit>
            <ci_upper_limit>5.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Response at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0763</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>3.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Response at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0216</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.13</ci_lower_limit>
            <ci_upper_limit>4.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Percentage of Participants With HAM-D Remission</title>
        <description>HAM-D Remission was defined as a HAM-D total score of less than or equal to (&lt;=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.</description>
        <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Percentage of Participants With HAM-D Remission</title>
          <description>HAM-D Remission was defined as a HAM-D total score of less than or equal to (&lt;=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.4"/>
                    <measurement group_id="O3" value="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18.9"/>
                    <measurement group_id="O3" value="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="23.3"/>
                    <measurement group_id="O3" value="44.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28.8"/>
                    <measurement group_id="O3" value="41.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30.4"/>
                    <measurement group_id="O3" value="53.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Remission at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0200</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.24</ci_lower_limit>
            <ci_upper_limit>12.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Remission at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0990</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>4.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Remission at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0110</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.24</ci_lower_limit>
            <ci_upper_limit>5.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Remission at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1982</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>3.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With HAM-D Remission at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0091</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline HAM-D total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.26</ci_lower_limit>
            <ci_upper_limit>5.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Change From Baseline in HAM-D Subscales Scores</title>
        <description>HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety [psychic and somatic], somatic symptoms [gastrointestinal and general], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
        <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in HAM-D Subscales Scores</title>
          <description>HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety [psychic and somatic], somatic symptoms [gastrointestinal and general], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Core: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-16.7" spread="1.91"/>
                    <measurement group_id="O3" value="-18.8" spread="1.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Core: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-23.4" spread="2.03"/>
                    <measurement group_id="O3" value="-28.7" spread="1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Core: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-26.8" spread="2.10"/>
                    <measurement group_id="O3" value="-31.9" spread="2.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Core: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-27.3" spread="2.24"/>
                    <measurement group_id="O3" value="-33.7" spread="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Core: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-29.5" spread="2.11"/>
                    <measurement group_id="O3" value="-37.2" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-16.4" spread="1.98"/>
                    <measurement group_id="O3" value="-23.5" spread="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-23.2" spread="2.15"/>
                    <measurement group_id="O3" value="-29.8" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-23.4" spread="2.19"/>
                    <measurement group_id="O3" value="-33.2" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-27.3" spread="2.17"/>
                    <measurement group_id="O3" value="-33.3" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-26.5" spread="2.19"/>
                    <measurement group_id="O3" value="-34.5" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bech-6: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-19.5" spread="2.45"/>
                    <measurement group_id="O3" value="-23.7" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bech-6: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-28.3" spread="2.58"/>
                    <measurement group_id="O3" value="-34.9" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bech-6: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-30.9" spread="2.61"/>
                    <measurement group_id="O3" value="-39.2" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bech-6: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-32.7" spread="2.72"/>
                    <measurement group_id="O3" value="-40.7" spread="2.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bech-6: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-34.6" spread="2.61"/>
                    <measurement group_id="O3" value="-44.0" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meier: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-17.0" spread="2.17"/>
                    <measurement group_id="O3" value="-21.7" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meier: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-25.0" spread="2.30"/>
                    <measurement group_id="O3" value="-32.2" spread="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meier: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-28.1" spread="2.35"/>
                    <measurement group_id="O3" value="-35.5" spread="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meier: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-29.9" spread="2.42"/>
                    <measurement group_id="O3" value="-37.0" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Meier: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-31.5" spread="2.32"/>
                    <measurement group_id="O3" value="-41.0" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Core: Change from Baseline in HAM-D Subscale Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3832</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.9</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Core: Change from Baseline in HAM-D Subscale Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0415</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.60</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.5</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Core: Change from Baseline in HAM-D Subscale Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0606</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.5</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Core: Change from Baseline in HAM-D Subscale Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0318</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.1</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Core: Change from Baseline in HAM-D Subscale Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0047</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.69</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>-2.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0053</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.0</ci_lower_limit>
            <ci_upper_limit>-2.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0181</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.76</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.1</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-9.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.82</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.3</ci_lower_limit>
            <ci_upper_limit>-4.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0332</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.5</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0048</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-8.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.5</ci_lower_limit>
            <ci_upper_limit>-2.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1840</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.3</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0462</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.2</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0150</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-8.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.9</ci_lower_limit>
            <ci_upper_limit>-1.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0245</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-8.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.0</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0054</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-9.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.0</ci_lower_limit>
            <ci_upper_limit>-2.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Meier: Change from Baseline in HAM-D Subscale Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0972</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.77</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.1</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Meier: Change from Baseline in HAM-D Subscale Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0155</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.95</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.1</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Meier: Change from Baseline in HAM-D Subscale Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0149</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.4</ci_lower_limit>
            <ci_upper_limit>-1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Meier: Change from Baseline in HAM-D Subscale Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0250</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-7.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.3</ci_lower_limit>
            <ci_upper_limit>-0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Meier: Change from Baseline in HAM-D Subscale Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0017</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D subscale score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-9.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.96</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.3</ci_lower_limit>
            <ci_upper_limit>-3.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Change From Baseline in HAM-D Individual Item Scores</title>
        <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.</description>
        <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in HAM-D Individual Item Scores</title>
          <description>The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Depressed Mood: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.13"/>
                    <measurement group_id="O3" value="-1.1" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depressed Mood: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="0.14"/>
                    <measurement group_id="O3" value="-1.7" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depressed Mood: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.5" spread="0.15"/>
                    <measurement group_id="O3" value="-1.8" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depressed Mood: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.5" spread="0.14"/>
                    <measurement group_id="O3" value="-2.1" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depressed Mood: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.7" spread="0.15"/>
                    <measurement group_id="O3" value="-2.1" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings of Guilt: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.12"/>
                    <measurement group_id="O3" value="-1.0" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings of Guilt: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.1" spread="0.13"/>
                    <measurement group_id="O3" value="-1.4" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings of Guilt: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="0.13"/>
                    <measurement group_id="O3" value="-1.5" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings of Guilt: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.2" spread="0.13"/>
                    <measurement group_id="O3" value="-1.6" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feelings of Guilt: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.5" spread="0.12"/>
                    <measurement group_id="O3" value="-1.8" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.2" spread="0.05"/>
                    <measurement group_id="O3" value="-0.3" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.2" spread="0.04"/>
                    <measurement group_id="O3" value="-0.4" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.3" spread="0.04"/>
                    <measurement group_id="O3" value="-0.3" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.2" spread="0.05"/>
                    <measurement group_id="O3" value="-0.3" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicide: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.2" spread="0.05"/>
                    <measurement group_id="O3" value="-0.4" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early - Early Night: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.2" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early - Early Night: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.3" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early - Early Night: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.3" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early - Early Night: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.1" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early - Early Night: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.0" spread="0.12"/>
                    <measurement group_id="O3" value="-1.1" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Middle - Middle Night: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.0" spread="0.11"/>
                    <measurement group_id="O3" value="-1.3" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Middle - Middle Night: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.0" spread="0.11"/>
                    <measurement group_id="O3" value="-1.3" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Middle - Middle Night: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.3" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Middle - Middle Night: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.11"/>
                    <measurement group_id="O3" value="-1.2" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Middle - Middle Night: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.3" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early Hours - Morning: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.11"/>
                    <measurement group_id="O3" value="-1.1" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early Hours - Morning: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.10"/>
                    <measurement group_id="O3" value="-1.2" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early Hours - Morning: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.0" spread="0.11"/>
                    <measurement group_id="O3" value="-1.2" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early Hours - Morning: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.0" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia Early Hours - Morning: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.10"/>
                    <measurement group_id="O3" value="-1.3" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and Activities: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.12"/>
                    <measurement group_id="O3" value="-0.9" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and Activities: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="0.14"/>
                    <measurement group_id="O3" value="-1.4" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and Activities: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.4" spread="0.14"/>
                    <measurement group_id="O3" value="-1.8" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and Activities: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.7" spread="0.16"/>
                    <measurement group_id="O3" value="-1.9" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work and Activities: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.7" spread="0.16"/>
                    <measurement group_id="O3" value="-2.1" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retardation: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="0.07"/>
                    <measurement group_id="O3" value="-0.4" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retardation: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.08"/>
                    <measurement group_id="O3" value="-0.8" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retardation: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.07"/>
                    <measurement group_id="O3" value="-0.8" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retardation: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.08"/>
                    <measurement group_id="O3" value="-0.8" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retardation: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.07"/>
                    <measurement group_id="O3" value="-1.0" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.4" spread="0.09"/>
                    <measurement group_id="O3" value="-0.7" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.09"/>
                    <measurement group_id="O3" value="-0.9" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.09"/>
                    <measurement group_id="O3" value="-0.9" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.09"/>
                    <measurement group_id="O3" value="-0.9" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Agitation: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.09"/>
                    <measurement group_id="O3" value="-1.1" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Psychic: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.12"/>
                    <measurement group_id="O3" value="-1.1" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Psychic: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.1" spread="0.14"/>
                    <measurement group_id="O3" value="-1.5" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Psychic: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.2" spread="0.13"/>
                    <measurement group_id="O3" value="-1.6" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Psychic: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="0.14"/>
                    <measurement group_id="O3" value="-1.6" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Psychic: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-1.3" spread="0.14"/>
                    <measurement group_id="O3" value="-1.7" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Somatic: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.10"/>
                    <measurement group_id="O3" value="-0.7" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Somatic: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.10"/>
                    <measurement group_id="O3" value="-0.9" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Somatic: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.11"/>
                    <measurement group_id="O3" value="-0.9" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Somatic: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.9" spread="0.11"/>
                    <measurement group_id="O3" value="-1.0" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Somatic: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.11"/>
                    <measurement group_id="O3" value="-1.0" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somatic Symptoms Gastrointestinal: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.3" spread="0.09"/>
                    <measurement group_id="O3" value="-0.6" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somatic Symptoms Gastrointestinal: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.10"/>
                    <measurement group_id="O3" value="-0.8" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somatic Symptoms Gastrointestinal: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.11"/>
                    <measurement group_id="O3" value="-1.0" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somatic Symptoms Gastrointestinal: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.11"/>
                    <measurement group_id="O3" value="-0.9" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somatic Symptoms Gastrointestinal: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.10"/>
                    <measurement group_id="O3" value="-1.0" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Somatic Symptoms: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.08"/>
                    <measurement group_id="O3" value="-0.7" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Somatic Symptoms: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.09"/>
                    <measurement group_id="O3" value="-0.9" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Somatic Symptoms: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.08"/>
                    <measurement group_id="O3" value="-1.1" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Somatic Symptoms: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.10"/>
                    <measurement group_id="O3" value="-1.0" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Somatic Symptoms: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.09"/>
                    <measurement group_id="O3" value="-1.0" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital Symptoms: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.3" spread="0.08"/>
                    <measurement group_id="O3" value="-0.4" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital Symptoms: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.10"/>
                    <measurement group_id="O3" value="-0.6" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital Symptoms: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.10"/>
                    <measurement group_id="O3" value="-0.9" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital Symptoms: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.10"/>
                    <measurement group_id="O3" value="-0.8" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Genital Symptoms: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.8" spread="0.10"/>
                    <measurement group_id="O3" value="-1.0" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypochondriasis: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="0.09"/>
                    <measurement group_id="O3" value="-0.7" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypochondriasis: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.08"/>
                    <measurement group_id="O3" value="-0.8" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypochondriasis: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="0.10"/>
                    <measurement group_id="O3" value="-1.0" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypochondriasis: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.08"/>
                    <measurement group_id="O3" value="-0.9" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypochondriasis: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.7" spread="0.09"/>
                    <measurement group_id="O3" value="-0.9" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Weight According to Patient: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.3" spread="0.08"/>
                    <measurement group_id="O3" value="-0.5" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Weight According to Patient: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.4" spread="0.07"/>
                    <measurement group_id="O3" value="-0.5" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Weight According to Patient: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="0.07"/>
                    <measurement group_id="O3" value="-0.5" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Weight According to Patient: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.6" spread="0.06"/>
                    <measurement group_id="O3" value="-0.6" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Weight According to Patient: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.5" spread="0.08"/>
                    <measurement group_id="O3" value="-0.6" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insight: Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.02"/>
                    <measurement group_id="O3" value="-0.1" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insight: Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.02"/>
                    <measurement group_id="O3" value="-0.1" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insight: Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.02"/>
                    <measurement group_id="O3" value="-0.1" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insight: Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.02"/>
                    <measurement group_id="O3" value="-0.1" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insight: Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0" spread="0.04"/>
                    <measurement group_id="O3" value="-0.1" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1569</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0376</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1035</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0037</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0061</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7878</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0498</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1719</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0161</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0191</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2537</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0018</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2878</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2594</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0086</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0424</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0207</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0010</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0871</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5680</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0143</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0063</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0042</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0137</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0099</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0507</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0205</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1409</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</non_inferiority_desc>
            <p_value>0.2021</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0117</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5511</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4949</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0203</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2076</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0362</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3589</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6991</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9655</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8699</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3715</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0670</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0104</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0122</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3157</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0077</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0078</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0372</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0244</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0993</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0185</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2471</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1076</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2782</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4646</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1600</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0474</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0446</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0093</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2998</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0545</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2177</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2300</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0151</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0502</p_value>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3659</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6003</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0785</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3668</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1827</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1327</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0993</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0056</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0122</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1305</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6638</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4341</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9085</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1820</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insight: Change From Baseline in HAM-D Individual Item Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1593</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insight: Change From Baseline in HAM-D Individual Item Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6555</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insight: Change From Baseline in HAM-D Individual Item Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0170</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insight: Change From Baseline in HAM-D Individual Item Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0188</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Insight: Change From Baseline in HAM-D Individual Item Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0726</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-D individual item score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.05</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score</title>
        <description>The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
        <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score</title>
          <description>The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-11.7" spread="1.36"/>
                    <measurement group_id="O3" value="-14.8" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-16.3" spread="1.45"/>
                    <measurement group_id="O3" value="-20.3" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-17.6" spread="1.48"/>
                    <measurement group_id="O3" value="-22.1" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-17.8" spread="1.49"/>
                    <measurement group_id="O3" value="-22.1" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-19.0" spread="1.44"/>
                    <measurement group_id="O3" value="-24.8" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in MADRS Total Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0791</p_value>
            <p_value_desc>MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.72</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.5</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in MADRS Total Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0322</p_value>
            <p_value_desc>MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.86</dispersion_value>
            <ci_percent>1.86</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.7</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change From Baseline in MADRS Total Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0180</p_value>
            <p_value_desc>MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.3</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in MADRS Total Score at 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0271</p_value>
            <p_value_desc>MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.92</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.1</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in MADRS Total Score at 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0018</p_value>
            <p_value_desc>MMRM was used for estimation with treatment with treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.82</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.4</ci_lower_limit>
            <ci_upper_limit>-2.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response</title>
        <description>The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.</description>
        <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response</title>
          <description>The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28.4"/>
                    <measurement group_id="O3" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="50.0"/>
                    <measurement group_id="O3" value="65.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="52.1"/>
                    <measurement group_id="O3" value="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="54.8"/>
                    <measurement group_id="O3" value="70.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="55.9"/>
                    <measurement group_id="O3" value="71.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With CGI-I Response at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3372</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>2.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With CGI-I Response at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0935</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>3.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With CGI-I Response at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0276</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.09</ci_lower_limit>
            <ci_upper_limit>4.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With CGI-I Response at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0920</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment: Baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>3.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With CGI-I Response at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1109</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline CGI-S score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>3.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score</title>
        <description>The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of &lt;17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.</description>
        <time_frame>Part B: Baseline, Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score</title>
          <description>The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of &lt;17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change From Baseline at Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-8.9" spread="1.02"/>
                    <measurement group_id="O3" value="-12.0" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-11.7" spread="1.04"/>
                    <measurement group_id="O3" value="-16.1" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-12.7" spread="1.09"/>
                    <measurement group_id="O3" value="-16.6" spread="1.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.1" spread="1.07"/>
                    <measurement group_id="O3" value="-16.6" spread="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 45</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-13.6" spread="1.02"/>
                    <measurement group_id="O3" value="-18.6" spread="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in HAM-A Total Score at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0169</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.7</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in HAM-A Total Score at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0010</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.0</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in HAM-A Total Score at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0063</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.7</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in HAM-A Total Score at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0119</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.2</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Change from Baseline in HAM-A Total Score at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <p_value_desc>MMRM was used for estimation with treatment, baseline HAM-A total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction as fixed effects.</p_value_desc>
            <method>Mixed Model for Repeated Measures</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.5</ci_lower_limit>
            <ci_upper_limit>-2.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Percentage of Participants With MADRS Response</title>
        <description>MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.</description>
        <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Percentage of Participants With MADRS Response</title>
          <description>MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="27.0"/>
                    <measurement group_id="O3" value="40.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="50.0"/>
                    <measurement group_id="O3" value="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="47.9"/>
                    <measurement group_id="O3" value="73.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="52.1"/>
                    <measurement group_id="O3" value="70.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="56.5"/>
                    <measurement group_id="O3" value="74.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Response at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1145</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>3.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Response at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1069</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>3.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Response at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0045</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.36</ci_lower_limit>
            <ci_upper_limit>5.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Response at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0421</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.01</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>3.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Response at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0541</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.99</ci_lower_limit>
            <ci_upper_limit>4.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Percentage of Participants With MADRS Remission</title>
        <description>MADRS Remission was defined as a MADRS total score of &lt;=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.</description>
        <time_frame>Part B: Days 3, 8, 15, 21 and 45</time_frame>
        <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Percentage of Participants With MADRS Remission</title>
          <description>MADRS Remission was defined as a MADRS total score of &lt;=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.</description>
          <population>Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="9.5"/>
                    <measurement group_id="O3" value="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28.4"/>
                    <measurement group_id="O3" value="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30.1"/>
                    <measurement group_id="O3" value="54.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="73"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="31.5"/>
                    <measurement group_id="O3" value="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="69"/>
                    <count group_id="O3" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="37.7"/>
                    <measurement group_id="O3" value="58.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Remission at Day 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0326</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.09</ci_lower_limit>
            <ci_upper_limit>7.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Remission at Day 8</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3749</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>2.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Remission at Day 15</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0087</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.26</ci_lower_limit>
            <ci_upper_limit>4.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Remission at Day 21</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0257</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.10</ci_lower_limit>
            <ci_upper_limit>4.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Percentage of Participants With MADRS Remission at Day 45</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0339</p_value>
            <p_value_desc>Generalized estimating equations for binary response model was used for estimation with factors for treatment, baseline MADRS total score, baseline antidepressant use, assessment time point, and time point-by-treatment interaction.</p_value_desc>
            <method>GEE for binary response model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>4.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.</description>
        <time_frame>Part A: Up to Day 75; Part B: Up to Day 45</time_frame>
        <population>Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
            <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.</description>
          <population>Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements</title>
        <description>Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.</description>
        <time_frame>Part B: From first dose of study drug up to 45 days</time_frame>
        <population>Safety Set (Part B) included all participants who were administered study drug in Part B of the study and analyzed by treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements</title>
          <description>Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.</description>
          <population>Safety Set (Part B) included all participants who were administered study drug in Part B of the study and analyzed by treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine SBP: &lt;90 millimeter of mercury (mmHg)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP: Decrease From Baseline of &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine SBP: Increase From Baseline of &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP: &lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP: Decrease From Baseline of &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing SBP: Increase From Baseline of &gt;=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP: &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP: Decrease From Baseline of &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP: Increase From Baseline of &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing DBP: &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing DBP: &gt;110 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing DBP: Decrease From Baseline of &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Standing DBP: Increase From Baseline of &gt;=20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations</title>
        <description>Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.</description>
        <time_frame>Part B: From first dose of study drug up to 45 days</time_frame>
        <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations</title>
          <description>Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.</description>
          <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematology: Eosinophils &gt;1.5 10^9/Liter(L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Hematocrit &lt;0.359</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Hematocrit &gt;0.446</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Hemoglobin &lt;110 g/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Leukocytes &lt;2.5 10^9/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Neutrophils &lt;1.5 10^9/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Alanine Aminotransferase &gt;3xUpper Limit of Normal Value (ULN)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Calcium &lt;2.0 millimoles (mmol)/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Chloride &lt;90 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Glucose &lt;2.8 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Glucose &gt;13.9 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Phosphate &gt;5 milligrams/deciliter (mg/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Potassium &lt;3.5 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Potassium &gt;5.2 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Chemistry: Sodium &gt;145 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate</title>
        <description>ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.</description>
        <time_frame>Part B: Baseline, Days 8, 15, and 21</time_frame>
        <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate</title>
          <description>ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.</description>
          <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.2" spread="9.55"/>
                    <measurement group_id="O2" value="69.9" spread="10.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="9.91"/>
                    <measurement group_id="O2" value="1.5" spread="12.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="8.16"/>
                    <measurement group_id="O2" value="0.9" spread="12.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change From Baseline at Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="8.93"/>
                    <measurement group_id="O2" value="-0.6" spread="11.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval</title>
        <description>ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.</description>
        <time_frame>Part B: Baseline, Days 8, 15, and 21</time_frame>
        <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval</title>
          <description>ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.</description>
          <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR Interval: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.4" spread="20.38"/>
                    <measurement group_id="O2" value="151.7" spread="17.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval: Change From Baseline at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="26.97"/>
                    <measurement group_id="O2" value="0.6" spread="11.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval: Change From Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="11.81"/>
                    <measurement group_id="O2" value="0.8" spread="11.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval: Change From Baseline at Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="14.66"/>
                    <measurement group_id="O2" value="2.5" spread="11.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="892.2" spread="131.63"/>
                    <measurement group_id="O2" value="871.6" spread="124.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval: Change From Baseline at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="137.12"/>
                    <measurement group_id="O2" value="-16.9" spread="149.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval: Change From Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="107.37"/>
                    <measurement group_id="O2" value="-8.4" spread="147.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval: Change From Baseline at Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.0" spread="113.89"/>
                    <measurement group_id="O2" value="13.9" spread="141.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.3" spread="9.50"/>
                    <measurement group_id="O2" value="90.2" spread="9.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration: Change From Baseline at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="8.19"/>
                    <measurement group_id="O2" value="-0.3" spread="6.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration: Change From Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="7.14"/>
                    <measurement group_id="O2" value="-0.3" spread="6.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration: Change From Baseline at Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="7.58"/>
                    <measurement group_id="O2" value="0.0" spread="6.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="395.1" spread="28.85"/>
                    <measurement group_id="O2" value="393.0" spread="28.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval: Change From Baseline at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" spread="24.23"/>
                    <measurement group_id="O2" value="-4.3" spread="29.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval: Change From Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="22.96"/>
                    <measurement group_id="O2" value="-2.7" spread="28.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval: Change From Baseline at Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.9" spread="23.70"/>
                    <measurement group_id="O2" value="0.1" spread="30.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="411.3" spread="20.92"/>
                    <measurement group_id="O2" value="412.2" spread="18.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval: Change From Baseline at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="15.80"/>
                    <measurement group_id="O2" value="-1.7" spread="15.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval: Change From Baseline at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="14.75"/>
                    <measurement group_id="O2" value="-1.5" spread="14.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval: Change From Baseline at Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="19.39"/>
                    <measurement group_id="O2" value="-1.8" spread="20.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part B: Number of Participants With a Response of &quot;Yes&quot; to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>C-SSRS was used to assess the suicidality of participants during the study. The assessment included &quot;yes&quot; or &quot;no&quot; responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.</description>
        <time_frame>Part B: Up to Day 45</time_frame>
        <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Part B: Placebo</title>
            <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>Part B: SAGE 217 30 mg Capsules</title>
            <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Part B: Number of Participants With a Response of &quot;Yes&quot; to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>C-SSRS was used to assess the suicidality of participants during the study. The assessment included &quot;yes&quot; or &quot;no&quot; responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.</description>
          <population>Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Suicidal Ideation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal Behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Part A: Up to Day 75; Part B: Up to Day 45</time_frame>
      <desc>Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part A: SAGE-217 15/20 mg Oral Solution</title>
          <description>Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.</description>
        </group>
        <group group_id="E2">
          <title>Part B: Placebo</title>
          <description>Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.</description>
        </group>
        <group group_id="E3">
          <title>Part B: SAGE 217 30 mg Capsules</title>
          <description>Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="73"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Sage Therapeutics</organization>
      <phone>(617) 299-8380</phone>
      <email>info@sagerx.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02978326
org study id: 217-PPD-201
nct id: NCT02978326
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study was to determine if treatment with SAGE-217 reduces
      depressive symptoms in participants with severe postpartum depression (PPD) compared to
      placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for
      Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of
      SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign
      measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the
      Columbia Suicide Severity Rating Scale (C-SSRS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
time frame: Parts A and B: Baseline, Day 15
description: The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
measure: Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45
time frame: Part B: Baseline, Days 3, 8, 21 and 45
description: The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
measure: Parts A and B: Percentage of Participants With HAM-D Response
time frame: Part B: Days 3, 8, 15, 21 and 45
description: HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.
measure: Parts A and B: Percentage of Participants With HAM-D Remission
time frame: Part B: Days 3, 8, 15, 21 and 45
description: HAM-D Remission was defined as a HAM-D total score of less than or equal to (<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours [morning]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.
measure: Parts A and B: Change From Baseline in HAM-D Subscales Scores
time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
description: HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety [psychic and somatic], somatic symptoms [gastrointestinal and general], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
measure: Parts A and B: Change From Baseline in HAM-D Individual Item Scores
time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
description: The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from Baseline indicates less depression.
measure: Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
description: The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
measure: Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
time frame: Part B: Days 3, 8, 15, 21 and 45
description: The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.
measure: Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
description: The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of <17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.
measure: Parts A and B: Percentage of Participants With MADRS Response
time frame: Part B: Days 3, 8, 15, 21 and 45
description: MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.
measure: Parts A and B: Percentage of Participants With MADRS Remission
time frame: Part B: Days 3, 8, 15, 21 and 45
description: MADRS Remission was defined as a MADRS total score of <=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.
measure: Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: Part A: Up to Day 75; Part B: Up to Day 45
description: An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
measure: Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
time frame: Part B: From first dose of study drug up to 45 days
description: Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.
measure: Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations
time frame: Part B: From first dose of study drug up to 45 days
description: Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.
measure: Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate
time frame: Part B: Baseline, Days 8, 15, and 21
description: ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.
measure: Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval
time frame: Part B: Baseline, Days 8, 15, and 21
description: ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.
measure: Part B: Number of Participants With a Response of "Yes" to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Part B: Up to Day 45
description: C-SSRS was used to assess the suicidality of participants during the study. The assessment included "yes" or "no" responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.
arm group label: Part A: SAGE-217 15/20 mg Oral Solution
arm group type: Experimental
description: Participants received SAGE-217, 15 milligrams (mg), oral solution, twice daily (BID) for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated.
arm group label: Part B: Placebo
arm group type: Placebo Comparator
description: Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
arm group label: Part B: SAGE 217 30 mg Capsules
arm group type: Experimental
description: Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
intervention type: Drug
intervention name: SAGE-217 15/20 mg Oral Solution
description: SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).
arm group label: Part A: SAGE-217 15/20 mg Oral Solution
intervention type: Drug
intervention name: Placebo
description: SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
arm group label: Part B: Placebo
intervention type: Drug
intervention name: SAGE 217 30 mg Capsules
description: SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
arm group label: Part B: SAGE 217 30 mg Capsules
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
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country: United States
url: http://www.sagerx.com
description: Related Info
citation: Deligiannidis K, Lasser R, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Assessment of Depressive Symptoms Across Multiple Measures. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.
citation: Lasser R, Deligiannidis K, Gunduz-Bruce H, Silber C, Sankoh AJ, Li Si, et al. A Phase 3, Double-Blind, Placebo- Controlled Trial of SAGE-217 in Postpartum Depression: Topline Assessment of Secondary Efficacy Measures of Anxiety and Depression. Abstract presented at: American Society of Clinical Psychopharmacology 2019 Annual Meeting; May 28-31, 2019; Scottsdale, AZ.
citation: Deligiannidis KM, Meltzer-Brody S, Gunduz-Bruce H, Doherty J, Jonas J, Li S, Sankoh AJ, Silber C, Campbell AD, Werneburg B, Kanes SJ, Lasser R. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):951-959. doi: 10.1001/jamapsychiatry.2021.1559. Erratum In: JAMA Psychiatry. 2022 Jul 1;79(7):740. JAMA Psychiatry. 2023 Feb 1;80(2):191.
PMID: 34190962
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
ipd description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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