A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia

ClinicalTrials.gov processed this data on June 25, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified June 2024 by Otsuka Pharmaceutical Development & Commercialization, Inc.


Otsuka Pharmaceutical Development & Commercialization, Inc.

Information Provided by (Responsible Party)

Otsuka Pharmaceutical Development & Commercialization, Inc.

Clinicaltrials.gov Identifier

Other Study ID Numbers: SEP361-301
First Submitted: August 26, 2019
First Posted: August 28, 2019
Last Update Posted: June 26, 2024
Last Verified: June 2024
History of Changes

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Study Description

This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (50 and 75 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food.

This study is designed to test the hypothesis that, treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.
Condition or Disease Intervention/Treatment
  • Schizophrenia
  • Drug: SEP-363856 50mg
  • Drug: SEP-363856 75mg
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment463 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia
Study Start DateSeptember 11, 2019
Actual Primary Completion DateMay 12, 2023
Actual Study Completion DateSeptember 12, 2023

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • SEP-363856 50mg
    • SEP-363856 50mg dosed once daily
  • Drug: SEP-363856 50mg
    • SEP-363856 50mg tablet dosed once daily
  • SEP-363856 75mg
    • SEP-363856 75mg dosed once daily
  • Drug: SEP-363856 75mg
    • Placebo
      • Placebo dosed once daily
    • Drug: Placebo

      Outcome Measures

      Primary Outcome Measures

      1. Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) [Baseline and Week 6]
        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.

      Secondary Outcome Measures

      1. Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) [Baseline and Week 6]
        The CGI-S is 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.

      Eligibility Criteria

      Ages Eligible for Study 13 Years to 65 Years (Child, Adult, Older Adult)
      Sexes Eligible for Study All
      Accepts Healthy Volunteers No
      Inclusion Criteria
      • Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
      • Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
      • Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
      • Subject must have a CGI-S score ≥ 4
      • Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
      • Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
      • Subject has marked deterioration of functioning in one or more areas.
      • Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values.
      Exclusion Criteria
      • Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months or lifetime history of significant substance abuse that in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
      • Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
      • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study:
      • Female subject who is pregnant or lactating
      • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

      Contacts and Locations

      Sponsors and Collaborators Otsuka Pharmaceutical Development & Commercialization, Inc.
      • Woodland International Research Group, LLC | Little Rock, Arkansas, United States, 72211
      • Advanced Research Center, Inc. | Anaheim, California, United States, 92805
      • CITrials | Bellflower, California, United States, 90706
      • Synergy San Diego | Lemon Grove, California, United States, 91945
      • Alliance for Research | Long Beach, California, United States, 90807
      • Catalina Research Institute | Montclair, California, United States, 91763
      • California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC) | Pico Rivera, California, United States, 90660
      • UCSD Medical Center,UCSD Department of Psychiatry | San Diego, California, United States, 92103-8229
      • Larkin Behavioral Health Services | Hollywood, Florida, United States, 33021
      • Research Centers of America | Hollywood, Florida, United States, 33024
      • South Florida Research Phase I-IV, Inc. | Miami Springs, Florida, United States, 33166
      • Advanced Discovery Research LLC | Atlanta, Georgia, United States, 30318
      • Atlantic Center for Medical Research | Atlanta, Georgia, United States, 30331
      • iResearch Atlanta, LLC | Decatur, Georgia, United States, 30030
      • CBH Health, LLC | Gaithersburg, Maryland, United States, 20877
      • Precise Research Centers | Flowood, Mississippi, United States, 39232
      • Midwest Clinical Research Center | Dayton, Ohio, United States, 45417
      • Community Clinical Research | Austin, Texas, United States, 78754
      • State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman | Pazardzhik, Bulgaria, 4400
      • UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic | Pleven, Bulgaria, 5800
      • Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders | Sofia, Bulgaria, 1202
      • UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry | Sofia, Bulgaria, 1431
      • UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry | Sofia, Bulgaria, 1431
      • Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders | Veliko Tarnovo, Bulgaria, 5000
      • Mental Health Center - Vratsa EOOD-Department of General Psychiatry | Vratsa, Bulgaria, 3000
      • E.S.E Hospital Mental de Antioquia - Unidad de Investigación | Bello, Antioquia, Colombia, 051053
      • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda | Bogota, Colombia,
      • Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Bogota, Colombia,
      • Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda | Bogotá, Colombia, 111166
      • State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1 | Chelyabinsk, Russian Federation, 454087
      • SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin" | Moscow, Russian Federation, 107076
      • State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod | Nizniy Novgorod, Russian Federation, 603155
      • State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital" | Petrozavodsk, Russian Federation, 186131
      • FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12 | Saint Petersburg, Russian Federation, 192019
      • State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital" | Samara, Russian Federation, 443016
      • State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents | Saratov, Russian Federation, 410028
      • FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12 | St. petersburg, Russian Federation, 092019
      • Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry | Belgrade, Serbia, 11000
      • Clinical Center Nis, Center of Mental Health Protection | Belgrade, Serbia, 11000
      • Institute of Mental Health | Belgrade, Serbia, 11000
      • Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39 | Gornja Toponica, Serbia, 18202
      • Special Hospital for Psychiatric Diseases "Kovin", | Kovin, Serbia, 26220
      • Special Neuropsychiatric Hospital Kovin | Kovin, Serbia, 26220
      • Clinical Center Kragujevac, Clinic of Psychiatry | Kragujevac, Serbia, 34000
      • University Clinical Center Nis, Clinic of Psychiatry | Nis, Serbia, 18000
      • Special Hospital for Psychiatric Diseases "SVeti Vracevi", | Novi Knezevac, Serbia, 23330
      • Clinical Center of Vojvodina, Clinic of Psychiatry | Novi Sad, Serbia, 21000
      • Special Hospital for Psychiatric Diseases | Vrsac, Serbia, 26300
      • 15, Medychna St | Ivano-Frankivsk, Ukraine, 76011
      • 2-A Metalurgiv st | Kropyvnytskyi, Ukraine, 25491
      • Dr. Vladyslav Demchenko | Kyiv, Ukraine, 02192
      • 103 Kyrylivska St | Kyiv, Ukraine, 04080
      • Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25 | Lviv, Ukraine, 79021
      • 9 Academician Vorobiov St | Odesa, Ukraine, 65006
      • 1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region | Odesa, Ukraine, 67513
      • 1 Medychna St | Poltava, Ukraine, 36013
      • Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12 | Smila, Ukraine, 20708
      • Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital | Vinnytsia, Ukraine, 21005

      More Information

      Additional Relevant MeSH Terms

      • Schizophrenia
      • Schizophrenia Spectrum and Other Psychotic Disorders
      • Mental Disorders