<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/NCT04479852</url>
  </required_header>
  <id_info>
    <org_study_id>SP-624-201</org_study_id>
    <nct_id>NCT04479852</nct_id>
  </id_info>
  <brief_title>A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder</brief_title>
  <official_title>A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sirtsei Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sirtsei Pharmaceuticals, Inc.</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>
      This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as&#xD;
      compared to placebo in the treatment of adults with Major Depressive Disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Actual">June 27, 2022</completion_date>
  <primary_completion_date type="Actual">June 27, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <masking_description>Double-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Weeks 1, 2, and 3 in Montgomery Asberg Depression Rating Scale total score</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Weeks 1, 2, 3, and 4 in Clinical Global Impression - Severity (CGI-S) total score</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents &quot;normal&quot; and 7 represents &quot;most extremely ill&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 5 and change from Week 4 to Week 5 in MADRS total score</measure>
    <time_frame>Up to 5 weeks</time_frame>
    <description>The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 5 and change from Week 4 to Week 5 in CGI-S total score</measure>
    <time_frame>Up to 5 weeks</time_frame>
    <description>The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents &quot;normal&quot; and 7 represents &quot;most extremely ill&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The 17-item Hamilton Depression rating scale is used to assess the severity of depression. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=No difficulty/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 2 and Week 4 in the Sheehan Disability Scale (SDS)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The Sheehan Disability Scale is a 3-part scale that measures the degree of disruption on work, social and family life using an 11-point scale where 0 represents &quot;no disruption&quot; and 10 represents &quot;extreme disruption&quot;. In addition to the 11-point scale, participants are asked to indicate the number of days in the past week that were &quot;lost&quot; and numbers of days that were &quot;unproductive&quot;. The results of these questions have a range from 0 to 7. A total global functioning impairment score can be utilized by summing the scores from work, social and family life scales for a value range from 0 to 30.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR), is a 16 item self-reported scale where each item has a 4-point scale where 0 represents least impact scores while 3 represents greatest impact scores. Some questions are linked. The total score ranges from 0 to 27 where a higher score indicates more depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item satisfaction scale where each item has a 5-point scale. A score of 1 represents &quot;very poor satisfaction&quot;, while a score of 5 represents &quot;very good satisfaction&quot;. Only the first 14 items are summed for a total score that ranges from 14 to 70.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>SP-624</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily oral capsule, 20 mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily oral capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SP-624</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>SP-624</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to provide written informed consent to participate in the study&#xD;
&#xD;
          -  Males and females, aged 18 to 65 years&#xD;
&#xD;
          -  In generally good physical health&#xD;
&#xD;
          -  Body mass index (BMI) must be between 18 and 40 kg/m2&#xD;
&#xD;
          -  Females of reproductive potential and males with partners of reproductive potential&#xD;
             must agree to remain abstinent or use adequate and reliable contraception throughout&#xD;
             the study and for at least 30 days after the last dose of study drug&#xD;
&#xD;
          -  Subjects must meet criteria for moderate to severe Major Depressive Disorder, as&#xD;
             confirmed by the Mini International Neuropsychiatric Interview (MINI)&#xD;
&#xD;
          -  Willing and able to comply with the study design schedule and other requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breastfeeding, or less than six months postpartum at Screening&#xD;
&#xD;
          -  History or presence of any clinically significant medical condition, disease, or&#xD;
             surgical history that could jeopardize the safety of the subject or validity of the&#xD;
             study data, or interfere with the absorption, distribution, metabolism, or excretion&#xD;
             of the study drug&#xD;
&#xD;
          -  Failure to discontinue all psychoactive medications or psychoactive supplements&#xD;
             including antidepressants and mood stabilizers, within a time period prior to Baseline&#xD;
             corresponding to at least five half-lives of the medication in question&#xD;
&#xD;
          -  Presence of a clinically significant abnormality on physical examination or&#xD;
             electrocardiogram (ECG), including a corrected QT interval using Fridericia's formula&#xD;
             (QTcF) &gt;450 msec for males and &gt;470 msec for females&#xD;
&#xD;
          -  Presence of uncontrolled hypertension, defined as consistent systolic blood pressure&#xD;
             (SBP) &gt;160 mmHg or consistent diastolic blood pressure (DBP) &gt;95 mmHg despite present&#xD;
             therapy&#xD;
&#xD;
          -  Screening laboratory value(s) outside the laboratory reference range that are&#xD;
             considered to be clinically significant by the Investigator (clinical chemistry,&#xD;
             hematology, coagulation, and urinalysis)&#xD;
&#xD;
          -  Screening liver function tests (ALT, AST, Alkaline phosphatase) &gt; 2x the upper limit&#xD;
             of normal&#xD;
&#xD;
          -  Subjects who, in the opinion of the Investigator, are not suitable candidates for the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Greg Rigdon, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Sirtsei Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alea Research</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodland International Research Group</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodland Research Northwest</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Research</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Research Partners</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Artemis Institute for Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Research</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MCB Clinical Research Centers</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarkis Clinical Trials</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research</name>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Advanced Medical Research</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>iResearch Atlanta</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Medical Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capstone Clinical Research</name>
      <address>
        <city>Libertyville</city>
        <state>Illinois</state>
        <zip>60048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CBH Health</name>
      <address>
        <city>Gaithersburg</city>
        <state>Maryland</state>
        <zip>20877</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Research Group</name>
      <address>
        <city>Saint Charles</city>
        <state>Missouri</state>
        <zip>63304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altea Research Institute</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Berlin</city>
        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Emotional Fitness</name>
      <address>
        <city>Cherry Hill</city>
        <state>New Jersey</state>
        <zip>08002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hassman Research Institute</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPRI Clinical Trials</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Behavioral Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond Behavioral Associates</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hope Clinical Research</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of America</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Clinical Research Center</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cutting Edge Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Center for Clinical Investigations</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Center for Clinical Investigations</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Center for Clinical Research</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions, Inc.</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donald J. Garcia, Jr., MD, PA</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78737</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Future Search Trials of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Red Oak Psychiatry Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grayline Research Center</name>
      <address>
        <city>Wichita Falls</city>
        <state>Texas</state>
        <zip>76309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Core Clinical Research</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <disposition_first_submitted>June 8, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>June 8, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 13, 2023</disposition_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04479852
org study id: SP-624-201
nct id: NCT04479852
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as
      compared to placebo in the treatment of adults with Major Depressive Disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind
measure: Change from Baseline to Week 4 in Montgomery Asberg Depression Rating Scale (MADRS) total score
time frame: Up to 4 weeks
description: The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
measure: Change from Baseline to Weeks 1, 2, and 3 in Montgomery Asberg Depression Rating Scale total score
time frame: Up to 3 weeks
description: The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
measure: Change from Baseline to Weeks 1, 2, 3, and 4 in Clinical Global Impression - Severity (CGI-S) total score
time frame: Up to 4 weeks
description: The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".
measure: Change from Baseline to Week 5 and change from Week 4 to Week 5 in MADRS total score
time frame: Up to 5 weeks
description: The Montgomery Asberg Depression rating scale is a 10-item scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The total score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
measure: Change from Baseline to Week 5 and change from Week 4 to Week 5 in CGI-S total score
time frame: Up to 5 weeks
description: The CGI-S is a 7-point scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. A score of 1 represents "normal" and 7 represents "most extremely ill".
measure: Change from Baseline to Week 2 and Week 4 in the 17-item Hamilton Depression Rating Scale (HAM D-17) total score
time frame: Up to 4 weeks
description: The 17-item Hamilton Depression rating scale is used to assess the severity of depression. Individual items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4), with 0=No difficulty/absent and 4=most severe. The total score is the sum of individual items, ranging from 0 to 52; where a higher score indicates more depression.
measure: Change from Baseline to Week 2 and Week 4 in the Sheehan Disability Scale (SDS)
time frame: Up to 4 weeks
description: The Sheehan Disability Scale is a 3-part scale that measures the degree of disruption on work, social and family life using an 11-point scale where 0 represents "no disruption" and 10 represents "extreme disruption". In addition to the 11-point scale, participants are asked to indicate the number of days in the past week that were "lost" and numbers of days that were "unproductive". The results of these questions have a range from 0 to 7. A total global functioning impairment score can be utilized by summing the scores from work, social and family life scales for a value range from 0 to 30.
measure: Change from Baseline to Week 2 and Week 4 in the Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR)
time frame: Up to 4 weeks
description: The Quick Inventory of Depressive Symptomology - Self Report (QIDS-SR), is a 16 item self-reported scale where each item has a 4-point scale where 0 represents least impact scores while 3 represents greatest impact scores. Some questions are linked. The total score ranges from 0 to 27 where a higher score indicates more depression.
measure: Change from Baseline to Week 2 and Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
time frame: Up to 4 weeks
description: The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item satisfaction scale where each item has a 5-point scale. A score of 1 represents "very poor satisfaction", while a score of 5 represents "very good satisfaction". Only the first 14 items are summed for a total score that ranges from 14 to 70.
arm group label: SP-624
arm group type: Experimental
description: Daily oral capsule, 20 mg/day
arm group label: Placebo
arm group type: Placebo Comparator
description: Daily oral capsule
intervention type: Drug
intervention name: SP-624
description: Oral capsule
arm group label: SP-624
intervention type: Drug
intervention name: Placebo
description: Oral capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Greg Rigdon, PhD
role: Study Director
affiliation: Sirtsei Pharmaceuticals, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major