A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified May 2024 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information Provided by (Responsible Party)
Otsuka Pharmaceutical Development & Commercialization, Inc.
Clinicaltrials.gov Identifier
NCT04072354
Other Study ID Numbers:
SEP361-301
First Submitted
August 25, 2019
First Posted
August 27, 2019
Last Update Posted
June 25, 2024
Last Verified
May 2024

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Schizophrenia
Drug: SEP-363856 50mgDrug: SEP-363856 75mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment463 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
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 10, 2019
Actual Primary Completion DateMay 11, 2023
Actual Study Completion DateSeptember 11, 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
SEP-363856 75mg tablet dosed once daily
Placebo
Placebo dosed once daily
Drug: Placebo
Placebo tablet dosed once daily

Outcome Measures

Primary Outcome Measures
  1. Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (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)
    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(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent. 2. 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.. 3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening 4. Subject must have a CGI-S score ≥ 4 5. 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 6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent). 7. Subject has marked deterioration of functioning in one or more areas. 8. 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
1. 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. 2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment. 3. 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: 4. Female subject who is pregnant or lactating 5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

Contacts and Locations

Sponsors and CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.
Locations
Woodland International Research Group, LLC | Little Rock Arkansas, United States, 72211Advanced Research Center, Inc. | Anaheim California, United States, 92805CITrials | Bellflower California, United States, 90706Synergy San Diego | Lemon Grove California, United States, 91945Alliance for Research | Long Beach California, United States, 90807Catalina Research Institute | Montclair California, United States, 91763California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC) | Pico Rivera California, United States, 90660UCSD Medical Center,UCSD Department of Psychiatry | San Diego California, United States, 92103-8229Larkin Behavioral Health Services | Hollywood Florida, United States, 33021Research Centers of America | Hollywood Florida, United States, 33024South Florida Research Phase I-IV, Inc. | Miami Springs Florida, United States, 33166Advanced Discovery Research LLC | Atlanta Georgia, United States, 30318Atlantic Center for Medical Research | Atlanta Georgia, United States, 30331iResearch Atlanta, LLC | Decatur Georgia, United States, 30030CBH Health, LLC | Gaithersburg Maryland, United States, 20877Precise Research Centers | Flowood Mississippi, United States, 39232Midwest Clinical Research Center | Dayton Ohio, United States, 45417Community Clinical Research | Austin Texas, United States, 78754State 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, 4400UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic | Pleven , Bulgaria, 5800Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders | Sofia , Bulgaria, 1202UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry | Sofia , Bulgaria, 1431UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry | Sofia , Bulgaria, 1431Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders | Veliko Tarnovo , Bulgaria, 5000Mental Health Center - Vratsa EOOD-Department of General Psychiatry | Vratsa , Bulgaria, 3000E.S.E Hospital Mental de Antioquia - Unidad de Investigación | Bello Antioquia, Colombia, 051053Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda | Bogotá , Colombia, 111166Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda | Bogotá , Colombia, Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Bogotá , Colombia, State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1 | Chelyabinsk , Russia, 454087SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin" | Moscow , Russia, 107076State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod | Nizniy Novgorod , Russia, 603155State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital" | Petrozavodsk , Russia, 186131FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12 | Saint Petersburg , Russia, 092019FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12 | Saint Petersburg , Russia, 192019State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital" | Samara , Russia, 443016State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents | Saratov , Russia, 410028Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry | Belgrade , Serbia, 11000Clinical Center Nis, Center of Mental Health Protection | Belgrade , Serbia, 11000Institute of Mental Health | Belgrade , Serbia, 11000Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39 | Gornja Toponica , Serbia, 18202Special Hospital for Psychiatric Diseases "Kovin", | Kovin , Serbia, 26220Special Neuropsychiatric Hospital Kovin | Kovin , Serbia, 26220Clinical Center Kragujevac, Clinic of Psychiatry | Kragujevac , Serbia, 34000University Clinical Center Nis, Clinic of Psychiatry | Niš , Serbia, 18000Special Hospital for Psychiatric Diseases "SVeti Vracevi", | Novi Kneževac , Serbia, 23330Clinical Center of Vojvodina, Clinic of Psychiatry | Novi Sad , Serbia, 21000Special Hospital for Psychiatric Diseases | Vršac , Serbia, 2630015, Medychna St | Ivano-Frankivsk , Ukraine, 760112-A Metalurgiv st | Kropyvnytskyi , Ukraine, 25491Dr. Vladyslav Demchenko | Kyiv , Ukraine, 02192103 Kyrylivska St | Kyiv , Ukraine, 04080Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25 | Lviv , Ukraine, 790219 Academician Vorobiov St | Odesa , Ukraine, 650061, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region | Odesa , Ukraine, 675131 Medychna St | Poltava , Ukraine, 36013Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12 | Smila , Ukraine, 20708Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital | Vinnytsia , Ukraine, 21005