<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/NCT02969382</url>
  </required_header>
  <id_info>
    <org_study_id>SEP361-201</org_study_id>
    <secondary_id>2016-001555-41</secondary_id>
    <nct_id>NCT02969382</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia</brief_title>
  <official_title>A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma America, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely&#xD;
      psychotic adults with schizophrenia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, double-blind, parallel-group, flexibly-dosed, study&#xD;
      evaluating the efficacy and safety of SEP-363856 in acutely psychotic adult subjects with&#xD;
      schizophrenia using SEP-363856 (50 or 75 mg/day [ie, once daily]) versus placebo over a&#xD;
      4-week treatment period. Primary hypoathesis to be tested: H0: μSEP = μPBO versus H1: μSEP ≠&#xD;
      μPBO, where μSEP and μPBO are the mean changes from Baseline at Week 4 in PANSS total score&#xD;
      for the SEP-363856 and placebo arms, respectively. Subjects who complete study SEP361-201 may&#xD;
      be eligible to enroll in the open-label extension study SEP361-202.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>PANSS comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Positive subscale score means more severe outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Negative subscale score means more severe outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS General Psychopathology subscale score means more severe outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Brief Negative Symptom Scale (BNSS) Total Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form. Higher BNSS total score means more severe outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60). Higher MADRS total score means more severe outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement From Baseline in PANSS Total Score</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Overall AEs, Serious AEs (SAEs) and AEs (or SAEs) Leading to Discontinuation</measure>
    <time_frame>From first dose of study drug to last study visit, up to 5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Subjects With Suicidal Ideation Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Overall post-Baseline double-blind treatment period, up to 4 weeks</time_frame>
    <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Subjects With Suicidal Behavior Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Overall post-Baseline double-blind treatment period, up to 4 weeks</time_frame>
    <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Subjects With Suicidality Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Overall post-Baseline double-blind treatment period, up to 4 weeks</time_frame>
    <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">245</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>SEP-363856</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsule once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SEP-363856</intervention_name>
    <description>One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks</description>
    <arm_group_label>SEP-363856</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo - Cap</intervention_name>
    <description>One Placebo capsule daily for 4 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must give written informed consent and privacy authorization prior to&#xD;
             participation in the study. Separate consent will be obtained from a caregiver or&#xD;
             legal guardian if required by local law.&#xD;
&#xD;
          2. Subject must be willing and able to comply with the study procedures and visit&#xD;
             schedules, including required hospitalization for the washout period and the&#xD;
             double-blind treatment period, and must be able to understand and follow verbal and&#xD;
             written instructions.&#xD;
&#xD;
          3. Male or female subject between 18 to 40 years of age (inclusive) at the time of&#xD;
             consent.&#xD;
&#xD;
          4. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview&#xD;
             (using the DSM-5 as a reference and confirmed using the SCID-CT). The duration of the&#xD;
             subject's illness whether treated or untreated must be ≥ 6 months.&#xD;
&#xD;
          5. Subject must have a CGI-S score ≥ 4 (moderate or greater) at screening and Baseline&#xD;
             (Day 1).&#xD;
&#xD;
          6. Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2&#xD;
             or more of the following PANSS items: delusions, conceptual disorganization,&#xD;
             hallucinations, and unusual thought content at screening and Baseline (Day 1).&#xD;
&#xD;
          7. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months).&#xD;
&#xD;
             • Subject has marked deterioration of functioning in one or more areas, such as&#xD;
             occupational, social, or personal care or hygiene.&#xD;
&#xD;
             • Subject requires hospitalization for an acute psychotic exacerbation at the time of&#xD;
             screening or has been hospitalized for the purpose of treating an acute psychotic&#xD;
             exacerbation for no more than 2 consecutive weeks immediately before screening.&#xD;
&#xD;
             Subjects who have been hospitalized for more than 2 weeks for reasons unrelated to an&#xD;
             acute psychotic exacerbation may be included if such a hospitalization was for a&#xD;
             condition other than an acute psychotic relapse. For example, subjects in a long-term&#xD;
             hospital setting who have an acute exacerbation and are transferred to an acute unit&#xD;
             are eligible for the study.&#xD;
&#xD;
          8. Subject has had no more than 2 prior hospitalizations for the treatment of an acute&#xD;
             exacerbation of schizophrenia (not including the current hospitalization) This history&#xD;
             must be confirmed based on report by a reliable informant (eg., caregiver or family&#xD;
             member) or medical records available at the time of screening.&#xD;
&#xD;
          9. Subject's BMI must be at least 18 kg/m2 but no more than 35 kg/m2.&#xD;
&#xD;
         10. Female subject must have a negative serum pregnancy test at screening.11. Female&#xD;
             subject of reproductive potential agrees to remain abstinent or use adequate and&#xD;
             reliable contraception throughout the study and for at least 30 days after the last&#xD;
             dose of study drug has been taken. In the Investigator's judgment, the subject will&#xD;
             adhere to this requirement.&#xD;
&#xD;
               1. Adequate contraception is defined as continuous use of either two barrier methods&#xD;
                  (eg, condom and spermicide or diaphragm with spermicide) or a hormonal&#xD;
                  contraceptive.&#xD;
&#xD;
                  Acceptable hormonal contraceptives include the following: a) contraceptive&#xD;
                  implant (such as Norplant®) implanted at least 90 days prior to screening; b)&#xD;
                  injectable contraception (such as medroxyprogesterone acetate injection) given at&#xD;
                  least 14 days prior to screening; or c) oral contraception taken as directed for&#xD;
                  at least 30 days prior to screening.&#xD;
&#xD;
               2. Subjects who are of non-reproductive potential, ie, subject who is surgically&#xD;
                  sterile, has undergone tubal ligation, or is postmenopausal (defined as at least&#xD;
                  12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous&#xD;
                  amenorrhea with follicle stimulating hormone (FSH) concentrations within&#xD;
                  postmenopausal range as determined by laboratory analysis) are not required to&#xD;
                  remain abstinent or use adequate contraception.&#xD;
&#xD;
         11. Female subject of reproductive potential agrees to remain abstinent or use highly&#xD;
             effective and reliable contraception throughout the study and for at least 30 days&#xD;
             after the last dose of study drug has been taken (See Section 21 Appendix II Highly&#xD;
             Effective Protocol SEP361-201, Version 3.01 SEP-363856 Confidential and Proprietary 36&#xD;
             17 August 2017 Contraceptive procedures). In the Investigator's judgment, the subject&#xD;
             will adhere to this requirement.&#xD;
&#xD;
         12. Male subjects with female partner(s) of childbearing potential must agree to avoid&#xD;
             fathering a child and use highly effective methods of birth control (outlined in&#xD;
             Section 21) from screening until at least 30 days after the last study drug&#xD;
             administration.&#xD;
&#xD;
         13. Subject must be able and agree to remain off prior antipsychotic medication for the&#xD;
             duration of the study.&#xD;
&#xD;
         14. Subject must have a total score &lt; 5 on the SAS at Baseline (Day 1).&#xD;
&#xD;
         15. Subject is, in the opinion of the Investigator, generally healthy based on screening&#xD;
             medical history, PE, neurological examination, vital signs, clinical laboratory values&#xD;
             (hematology, serum chemistry, urinalysis, lipid panel, coagulation panel, thyroid&#xD;
             panel, and serum prolactin).&#xD;
&#xD;
         16. Subject has had a stable living arrangement at the time of screening and agrees to&#xD;
             return to a similar living arrangement after discharge. This criterion is not meant to&#xD;
             exclude subjects who have temporarily left a stable living arrangement (eg, due to&#xD;
             psychosis). Such subjects remain eligible to participate in this protocol. Chronically&#xD;
             homeless subjects should not be enrolled.&#xD;
&#xD;
         17. Subject must agree to comply with all restrictions for the required length of time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Subject answers &quot;yes&quot; to &quot;Suicidal Ideation&quot; Item 4 (active suicidal ideation with some&#xD;
        intent to act, without specific plan) or item 5 (active suicidal ideation with specific&#xD;
        plan and intent) on the C-SSRS assessment at or during the Screening period (ie, in the&#xD;
        past one month) and/or at Baseline (ie, since last visit).&#xD;
&#xD;
        2. Subject does not tolerate venipuncture or has poor venous access that would cause&#xD;
        difficulty for collecting blood samples.&#xD;
&#xD;
        3. Subject is currently participating, or has participated in, a study with an&#xD;
        investigational or marketed compound or device within 6 months prior to signing the&#xD;
        informed consent, or has participated in 2 or more studies within 24 months prior to&#xD;
        signing informed consent.&#xD;
&#xD;
        4. Subject has previously received SEP-363856. 5. Subject has any clinically significant&#xD;
        unstable medical condition or any clinically significant chronic disease that in the&#xD;
        opinion of the Investigator, would limit the subject's ability to complete and/or&#xD;
        participate in the study:&#xD;
&#xD;
          1. Hematological (including deep vein thrombosis) or bleeding disorder, renal, metabolic,&#xD;
             endocrine, pulmonary, gastrointestinal, urological, cardiovascular, hepatic,&#xD;
             neurologic, or allergic disease that is clinically significant or unstable (except for&#xD;
             untreated, asymptomatic, seasonal allergies at time of dosing).&#xD;
&#xD;
          2. Subject has a history of neuroleptic malignant syndrome. Protocol SEP361-201, Version&#xD;
             3.01 SEP-363856 Confidential and Proprietary 37 17 August 2017&#xD;
&#xD;
          3. Subject has a history of malignancy within 5 years prior to the Screening visit,&#xD;
             except for adequately treated basal cell or squamous cell skin cancer or in situ&#xD;
             cervical cancer. Pituitary tumors of any duration are excluded.&#xD;
&#xD;
          4. Disorder or history of a condition, or previous gastrointestinal surgery (eg,&#xD;
             cholecystectomy, vagotomy, bowel resection, or any surgical procedure) that may&#xD;
             interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal&#xD;
             motility, or pH, or a clinically significant abnormality of the hepatic or renal&#xD;
             system, or a history of malabsorption.&#xD;
&#xD;
          5. Subject has Alcohol or Substance Abuse Disorder (DSM-5 criteria). The only exceptions&#xD;
             include caffeine or nicotine.&#xD;
&#xD;
          6. Subject has a clinically significant abnormal 12-lead ECG that may jeopardize the&#xD;
             subject's ability to complete the study or a screening 12-lead ECG demonstrating any&#xD;
             one of the following: heart rate &gt; 100 beats per minute, QRS &gt; 120 ms, QT interval&#xD;
             corrected for heart rate using Fridericia's formula (QTcF) &gt; 450 ms (males), QTcF &gt;&#xD;
             470 ms (females), or PR &gt; 220 ms.&#xD;
&#xD;
          7. Subjects with known history of human immunodeficiency virus (HIV) seropositivity.6. 6.&#xD;
             Female subject who is pregnant or lactating.&#xD;
&#xD;
             7. Subject who has a lifelong history or presence of symptoms consistent with a major&#xD;
             psychiatric disorder other than schizophrenia as defined by DSM-5. Exclusionary&#xD;
             disorders include but are not limited to alcohol use disorder (within past 12 months),&#xD;
             substance (other than nicotine or caffeine) use disorder within past 12 months, major&#xD;
             depressive disorder, bipolar depression, mania, schizoaffective disorder, obsessive&#xD;
             compulsive disorder, posttraumatic stress disorder. Previous or current symptoms of&#xD;
             mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have&#xD;
             not been a focus of primary treatment.&#xD;
&#xD;
             8. Subject tests positive for drugs of abuse at screening, however, a positive test&#xD;
             for amphetamines, barbiturates, opiates, benzodiazepines may not result in exclusion&#xD;
             of subjects if the investigator determines that the positive test is as a result of&#xD;
             prescription medicine(s). In the event a subject tests positive for cannabinoids&#xD;
             (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to&#xD;
             abstain from using this substance during the study. This information will be discussed&#xD;
             with the Medical Monitor prior to study enrollment.&#xD;
&#xD;
             9. Subject is at significant risk of harming self, others or objects based on the&#xD;
             Investigator's judgment.&#xD;
&#xD;
             10. Subject has attempted suicide within 3 months prior to screening. 11. Subject is&#xD;
             involuntarily hospitalized. 12. Subject has received depot antipsychotics unless the&#xD;
             last injection was at least one treatment cycle or at least 30 days (whichever is&#xD;
             longer), prior to the screening phase.&#xD;
&#xD;
             13. Subject is judged to be resistant to antipsychotic treatment by the Investigator,&#xD;
             based on failure to respond to 2 or more marketed antipsychotic agents, given at&#xD;
             adequate dose for at least 4 weeks within a 1 year period prior to Screening.&#xD;
&#xD;
             14. Subject has a history of treatment with clozapine for refractory psychosis and/or&#xD;
             subject has been treated with clozapine (for any reason) within 4 months of Screening.&#xD;
&#xD;
             15. Subject is receiving a total dose of antipsychotic medication equivalent to &gt; 12.0&#xD;
             mg/day of haloperidol at Screening (see Section 22, Appendix III for table of&#xD;
             haloperidol dose equivalents). Subject may be eligible if such treatment is less than&#xD;
             2 weeks in duration after consultation with the Medical Monitor.&#xD;
&#xD;
             16. Subject has received electroconvulsive therapy treatment within the 3 months prior&#xD;
             to screening or is expected to require ECT during the study.&#xD;
&#xD;
             17. Subject takes or has taken other disallowed recent or concomitant medications (see&#xD;
             Section 10.3). Subjects must taper off antipsychotic medications by Day -1.&#xD;
&#xD;
             18. Subject has a history of allergic reaction or suspected sensitivity to any&#xD;
             substance that is contained in the formulation (gelatin).&#xD;
&#xD;
             19. Subject has any clinically significant abnormal laboratory values (hematology,&#xD;
             serum chemistry, urinalysis, lipid panel, coagulation panel, thyroid panel, and serum&#xD;
             prolactin (Note: abnormal findings that may be clinically significant or of&#xD;
             questionable significance will be discussed with the Medical Monitor prior to&#xD;
             including subject).&#xD;
&#xD;
             20. Subject demonstrates evidence of acute hepatitis, clinically significant chronic&#xD;
             hepatitis, or evidence of clinically significant impaired hepatic function through&#xD;
             clinical and laboratory evaluation.&#xD;
&#xD;
             Note: Subjects with serum alanine transaminase (ALT) or aspartate transaminase (AST)&#xD;
             levels ≥ 3 times the upper limit of the reference ranges provided by the central&#xD;
             laboratory require retesting. If on retesting, the laboratory value remains ≥ 3 times&#xD;
             the upper limit, the subject will be excluded.&#xD;
&#xD;
             21. Subject has a serum blood urea nitrogen (BUN) or serum creatinine (Cr) value ≥ 1.5&#xD;
             times the upper limit of normal for the reference range.&#xD;
&#xD;
             22. Subject has experienced significant blood loss (≥ 473 mL) or donated blood within&#xD;
             60 days prior to first dose of study drug; has donated plasma within 72 hours prior to&#xD;
             the first dose of study drug or intends to donate plasma or blood or undergo elective&#xD;
             surgery during study participation or within 60 days after the last study visit.&#xD;
&#xD;
             23. Subject has used disallowed prescription or disallowed nonprescription drugs,&#xD;
             vitamins, or dietary or herbal supplements within 14 days prior to dosing or&#xD;
             anticipates the need for any disallowed medication during their participation in this&#xD;
             study [exception: female subjects who are taking oral, patch, or intrauterine device&#xD;
             (IUD) hormonal contraceptives, or progestin implant or injection].&#xD;
&#xD;
             24. Subject is a staff member or the relative of a staff member. 25. Subjects with a&#xD;
             fasting blood glucose at screening ≥ 126 mg/dL (7.0 mmol/L) or HbA1c ≥ 6.5% will be&#xD;
             excluded.&#xD;
&#xD;
             26. Subject has a prolactin concentration &gt; 100 ng/mL at screening or has a history of&#xD;
             pituitary adenoma. NOTE: Subjects with prolactin levels &gt; 100 ng/mL and ≤ 200 ng/mL&#xD;
             Protocol SEP361-201, Version 3.01 SEP-363856 Confidential and Proprietary 39 17 August&#xD;
             2017 at the Screening visit are permitted to enroll after discussion with the Medical&#xD;
             Monitor to ensure exclusion of non-psychotropic drug-related causes of elevated&#xD;
             prolactin levels.&#xD;
&#xD;
             27. .Subject is in the opinion of the Investigator, unsuitable in any other way to&#xD;
             participate in this study.&#xD;
&#xD;
             Randomization Criteria&#xD;
&#xD;
               1. Subject must have a PANSS total score ≥ 80 at Baseline (Day 1).&#xD;
&#xD;
               2. Subject must have a PANSS item score ≥ 4 on 2 or more of the following PANSS&#xD;
                  items: delusions, conceptual disorganization, hallucinations, and unusual thought&#xD;
                  content at Baseline (Day 1).3. Subject must have a CGI-S score ≥ 4 at Baseline&#xD;
                  (Day 1).&#xD;
&#xD;
               3. Subject must not demonstrate a decrease (improvement) of ≥ 20% in the PANSS total&#xD;
                  score between Screening and Baseline visits, or the PANSS total score falls below&#xD;
                  80 at Baseline (Day 1).&#xD;
&#xD;
               4. Subject must have a total score &lt; 5 on the SAS at Baseline (Day 1).&#xD;
&#xD;
               5. Subject must have a total score &lt; 5 on the SAS at Baseline (Day 1).&#xD;
&#xD;
               6. Subject must not answer &quot;yes&quot; to &quot;Suicidal Ideation&quot; Item 4 (active suicidal&#xD;
                  ideation with some intent to act, without specific plan) or Item 5 (active&#xD;
                  suicidal ideation with specific plan and intent) on the C-SSRS assessment at&#xD;
                  Baseline (ie, since last visit).&#xD;
&#xD;
               7. Subject must meet all other inclusion and none of the exclusion criteria at&#xD;
                  Baseline (Day 1).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CNS Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sumitomo Pharma America, Inc.</affiliation>
  </overall_official>
  <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>Collaborative Neuroscience Network, LLC</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Neuropsychopharmacology Clinical Research Institute-LA, LLC(CNRI- LA, LLC)</name>
      <address>
        <city>Pico Rivera</city>
        <state>California</state>
        <zip>90660</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>Lake Charles Clinical Trials</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70629</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pillar Clinical Research, LLC</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitacios Elmegyogyaszati osztaly</name>
      <address>
        <city>Gyongyos</city>
        <zip>3200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza</name>
      <address>
        <city>Gyula</city>
        <zip>5700</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucuresti</city>
        <zip>010825</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri &quot;Sfantul Stelian&quot; - C.E.T.T.T. &quot;Sf. Stelian&quot;</name>
      <address>
        <city>Bucuresti</city>
        <zip>060222</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Neuropsihiatrie Craiova</name>
      <address>
        <city>Craiova</city>
        <zip>200473</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul de Psihiatrie Socola Iasi, Sectia Clinica III Acuti, Sos. Bucium</name>
      <address>
        <city>Iasi</city>
        <zip>700282</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Republic Karelia &quot;Republican Psychiatric Hospital&quot;</name>
      <address>
        <city>Matrosy</city>
        <state>Republic Karelia</state>
        <zip>186131</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>300195230</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Petersburg State Budgetary Institution of Healthcare &quot;Psychiatric Hospital #1 named after P.P. Kashchenko&quot;</name>
      <address>
        <city>Leningrad</city>
        <zip>188357</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Scientific Instittuion &quot;Scientific Center of Mental Health</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Psychiatric Hospital of St. Nikolay Chudotvorets</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>190121</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI Saint Petersburg Scientifc and Research Psychoneurological Instatitute named after V.M Bekhterev</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>192019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPHI &quot;City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>300151369</name>
      <address>
        <city>Saratov</city>
        <zip>410060</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBEI HPE &quot;Smolensk State Medical University&quot; of the MoH of the RF</name>
      <address>
        <city>Smolensk</city>
        <zip>214019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>300173524</name>
      <address>
        <city>St. Petersburg</city>
        <zip>198020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Crisis Cond &amp; Primary Psych Episode #1</name>
      <address>
        <city>Ivano Frankivsk</city>
        <zip>76014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch of Psychiatry, Narcology and Med Psychol</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatric Department of Primary Psychotic Episodes</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unit of Emergency Psychiatry and Narcology</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Psychiarty #3 (male) and #10 (female)</name>
      <address>
        <city>Kherson</city>
        <zip>73488</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TMA Psychiatry in Kyiv Center of NT &amp; Rehabilitation of Psychotic Conditions</name>
      <address>
        <city>Kyiv</city>
        <zip>04080</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CI Odesa Regional Medical Center of Mental Health</name>
      <address>
        <city>Odesa</city>
        <zip>65006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Femal Dept #11, Male Dept #12</name>
      <address>
        <city>Smila</city>
        <zip>20708</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch of Neurology, Psychiatry, Narcology and MP</name>
      <address>
        <city>Ternopil</city>
        <zip>46020</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Psychiatry</name>
      <address>
        <city>Uzhgorod</city>
        <zip>88000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch of Psychiatry and Narcology</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>July 28, 2021</results_first_submitted>
  <results_first_submitted_qc>August 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 22, 2021</results_first_posted>
  <disposition_first_submitted>July 30, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 30, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 7, 2019</disposition_first_posted>
  <last_update_submitted>August 25, 2021</last_update_submitted>
  <last_update_submitted_qc>August 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study may be made available upon request via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available upon request within 12 months of posting the study results on ct.gov.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </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>August 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02969382/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>August 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02969382/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo capsule once daily</description>
        </group>
        <group group_id="P2">
          <title>SEP-363856</title>
          <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="125"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Subjects Continued Into Extension Study</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>PROTOCOL DEVIATION</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo capsule once daily</description>
        </group>
        <group group_id="B2">
          <title>SEP-363856</title>
          <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
        </group>
        <group group_id="B3">
          <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="125"/>
            <count group_id="B2" value="120"/>
            <count group_id="B3" value="245"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="243"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.6" spread="6.07"/>
                    <measurement group_id="B2" value="30.0" spread="5.76"/>
                    <measurement group_id="B3" value="30.3" spread="5.91"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="234"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="104"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&gt;=18 - &lt;25 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=25 - &lt;=40 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Height (cm)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.7" spread="7.78"/>
                    <measurement group_id="B2" value="173.0" spread="8.50"/>
                    <measurement group_id="B3" value="172.8" spread="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Weight (kg)</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.74" spread="12.645"/>
                    <measurement group_id="B2" value="75.23" spread="15.768"/>
                    <measurement group_id="B3" value="74.47" spread="14.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Body Mass Index (kg/m^2)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.71" spread="3.727"/>
                    <measurement group_id="B2" value="25.01" spread="4.238"/>
                    <measurement group_id="B3" value="24.86" spread="3.981"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Body Mass Index (BMI) Group</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;18.5 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=18.5 - &lt;25.0 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=25.0 - &lt;30.0 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=30.0 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Waist Circumference (cm)</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84.18" spread="12.186"/>
                    <measurement group_id="B2" value="85.21" spread="14.191"/>
                    <measurement group_id="B3" value="84.68" spread="13.189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Country</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hungary</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Romania</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Russia</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ukraine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>United States</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4</title>
        <description>PANSS comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4</title>
          <description>PANSS comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.</description>
          <units>Units 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="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="1.61"/>
                    <measurement group_id="O2" value="-17.2" spread="1.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-7.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.9</ci_lower_limit>
            <ci_upper_limit>-3.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4</title>
        <description>The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4</title>
          <description>The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.</description>
          <units>Units 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="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.09"/>
                    <measurement group_id="O2" value="-1.0" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.5</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_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score at Week 4</title>
        <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Positive subscale score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score at Week 4</title>
          <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Positive subscale score means more severe outcome.</description>
          <units>Units 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="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="0.51"/>
                    <measurement group_id="O2" value="-5.5" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score at Week 4</title>
        <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Negative subscale score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score at Week 4</title>
          <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Negative subscale score means more severe outcome.</description>
          <units>Units 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="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="0.41"/>
                    <measurement group_id="O2" value="-3.1" spread="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.55</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.6</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 4</title>
        <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS General Psychopathology subscale score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 4</title>
          <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS General Psychopathology subscale score means more severe outcome.</description>
          <units>Units 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="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="0.84"/>
                    <measurement group_id="O2" value="-9.0" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.6</ci_lower_limit>
            <ci_upper_limit>-2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Brief Negative Symptom Scale (BNSS) Total Score at Week 4</title>
        <description>The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form. Higher BNSS total score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>Subjects who had BNSS total score data available are included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Brief Negative Symptom Scale (BNSS) Total Score at Week 4</title>
          <description>The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form. Higher BNSS total score means more severe outcome.</description>
          <population>Subjects who had BNSS total score data available are included in this analysis.</population>
          <units>Units 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="119"/>
                <count group_id="O2" value="113"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="0.91"/>
                    <measurement group_id="O2" value="-7.1" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-4.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.8</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4</title>
        <description>The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60). Higher MADRS total score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4</title>
          <description>The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60). Higher MADRS total score means more severe outcome.</description>
          <units>Units 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="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="0.57"/>
                    <measurement group_id="O2" value="-3.3" spread="0.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.020</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-1.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.2</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement From Baseline in PANSS Total Score</title>
        <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>Subjects who had PANSS total score data available at both Baseline and Week 4 are included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement From Baseline in PANSS Total Score</title>
          <description>PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.</description>
          <population>Subjects who had PANSS total score data available at both Baseline and Week 4 are included in this analysis.</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="100"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.645</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.422</ci_lower_limit>
            <ci_upper_limit>4.921</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Incidence of Overall AEs, Serious AEs (SAEs) and AEs (or SAEs) Leading to Discontinuation</title>
        <time_frame>From first dose of study drug to last study visit, up to 5 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>The Incidence of Overall AEs, Serious AEs (SAEs) and AEs (or SAEs) Leading to Discontinuation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall Adverse Events (AEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events (SAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs/SAEs leading to discontinuation from study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs/SAEs leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Subjects With Suicidal Ideation Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
        <time_frame>Overall post-Baseline double-blind treatment period, up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Subjects With Suicidal Ideation Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.498</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Subjects With Suicidal Behavior Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
        <time_frame>Overall post-Baseline double-blind treatment period, up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Subjects With Suicidal Behavior Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.999</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Subjects With Suicidality Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
        <time_frame>Overall post-Baseline double-blind treatment period, up to 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo capsule once daily</description>
          </group>
          <group group_id="O2">
            <title>SEP-363856</title>
            <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Subjects With Suicidality Using the Columbia - Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.498</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 weeks (from first dose of study drug to last study visit)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo capsule once daily</description>
        </group>
        <group group_id="E2">
          <title>SEP-363856</title>
          <description>SEP-363856 capsule (50 mg or 75 mg) once daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</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="125"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="125"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="125"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="47" subjects_at_risk="125"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="125"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="125"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="125"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="125"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="13" subjects_at_risk="125"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="125"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="125"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="120"/>
              </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>In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>CNS Medical Director</name_or_title>
      <organization>Sunovion Pharmaceuticals, Inc.</organization>
      <phone>1-866-503-6351</phone>
      <email>CLINICALTRIALDISCLOSURE@SUNOVION.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/NCT02969382
org study id: SEP361-201
secondary id: 2016-001555-41
nct id: NCT02969382
lead sponsor: 
has dmc: No
A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely
      psychotic adults with schizophrenia
This is a multicenter, randomized, double-blind, parallel-group, flexibly-dosed, study
      evaluating the efficacy and safety of SEP-363856 in acutely psychotic adult subjects with
      schizophrenia using SEP-363856 (50 or 75 mg/day [ie, once daily]) versus placebo over a
      4-week treatment period. Primary hypoathesis to be tested: H0: μSEP = μPBO versus H1: μSEP ≠
      μPBO, where μSEP and μPBO are the mean changes from Baseline at Week 4 in PANSS total score
      for the SEP-363856 and placebo arms, respectively. Subjects who complete study SEP361-201 may
      be eligible to enroll in the open-label extension study SEP361-202.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
time frame: Baseline, Week 4
description: PANSS comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4
time frame: Baseline, Week 4
description: The CGI-S a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score at Week 4
time frame: Baseline, Week 4
description: PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Positive subscale score means more severe outcome.
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score at Week 4
time frame: Baseline, Week 4
description: PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS Negative subscale score means more severe outcome.
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 4
time frame: Baseline, Week 4
description: PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS General Psychopathology subscale score means more severe outcome.
measure: Change From Baseline in Brief Negative Symptom Scale (BNSS) Total Score at Week 4
time frame: Baseline, Week 4
description: The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form. Higher BNSS total score means more severe outcome.
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
time frame: Baseline, Week 4
description: The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60). Higher MADRS total score means more severe outcome.
measure: Positive and Negative Syndrome Scale (PANSS) Response at Week 4, Defined as a 20% or Greater Improvement From Baseline in PANSS Total Score
time frame: Baseline, Week 4
description: PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.
measure: The Incidence of Overall AEs, Serious AEs (SAEs) and AEs (or SAEs) Leading to Discontinuation
time frame: From first dose of study drug to last study visit, up to 5 weeks
measure: Frequency of Subjects With Suicidal Ideation Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
time frame: Overall post-Baseline double-blind treatment period, up to 4 weeks
description: The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
measure: Frequency of Subjects With Suicidal Behavior Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
time frame: Overall post-Baseline double-blind treatment period, up to 4 weeks
description: The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
measure: Frequency of Subjects With Suicidality Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
time frame: Overall post-Baseline double-blind treatment period, up to 4 weeks
description: The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
arm group label: SEP-363856
arm group type: Experimental
description: SEP-363856 capsule (50 mg or 75 mg) once daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsule once daily
intervention type: Drug
intervention name: SEP-363856
description: One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks
arm group label: SEP-363856
intervention type: Drug
intervention name: Placebo - Cap
description: One Placebo capsule daily for 4 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: CNS Medical Director
role: Study Director
affiliation: Sumitomo Pharma America, Inc.
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country: Hungary
country: Romania
country: Russian Federation
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: Yes
ipd description: IPD for this study may be made available upon request via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
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