A Clinical Trial That Will 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
NCT04092686
Other Study ID Numbers:
361-302
First Submitted
September 12, 2019
First Posted
September 16, 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 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. 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 hypotheses 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 75mgDrug: SEP-363856 100mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment464 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 29, 2019
Actual Primary Completion DateJune 13, 2023
Actual Study Completion DateJune 13, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
SEP-363856 75mg
SEP-363856 75mg dosed once daily
Drug: SEP-363856 75mg
SEP-363856 75mg tablet dosed once daily
SEP-363856 100mg
SEP-363856 100mg dosed once daily
Drug: SEP-363856 100mg
SEP-363856 100mg 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(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Male or female subject between 18 to 65 years of age (inclusive) at the time of consent. 2. Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent. 3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing. 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 on 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 investigator.

Contacts and Locations

Sponsors and CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.
Locations
Woodland Research Northwest | Rogers Arkansas, United States, 72758Advanced Research Center, Inc. | Anaheim California, United States, 92805Clinical Innovations, Inc. | Bellflower California, United States, 90706ProScience Research Group | Culver City California, United States, 90230Collaborative Neuroscience Network | Long Beach California, United States, 90806California Neuropsychopharmacology Clinical Research Institute | San Diego California, United States, 92102Schuster Medical Research Institute | Sherman Oaks California, United States, 91403Larkin Behavioral Health Services | Hollywood Florida, United States, 33021South Florida Research Phase I-IV, INC. | Miami Springs Florida, United States, 33166Atlanta Center for Medical Research | Atlanta Georgia, United States, 30331iResearch Atlanta, LLC | Decatur Georgia, United States, 30030Pillar Clinical Research | Chicago Illinois, United States, 60641Lake Charles Clinical Trials | Lake Charles Louisiana, United States, 70629CBH Health, LLC | Gaithersburg Maryland, United States, 20877Arch Clinical Trials, LLC | St Louis Missouri, United States, 63125Hassman Research Institute | Marlton New Jersey, United States, 08053New York State Psychiatric Institute | New York New York, United States, 10032Pillar Clinical Research | Richardson Texas, United States, 75080Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions | Burgas , Bulgaria, 8000State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment | Kardzhali , Bulgaria, 6600State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - Women | Novi Iskar , Bulgaria, 1282UMHAT Sveti Georgi EAD | Plovdiv , Bulgaria, 4000Mental Health Center - Sofia EOOD Unit for Active Treatment of Persons with Serious Mental Disorders | Sofia , Bulgaria, 1202UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry | Sofia , Bulgaria, 1431Psychiatric Hospital "Sveti Ivan" | Zagreb , Croatia, 10090LTD Psychoeurological Hospital of Daugavpils | Daugavpils , Latvia, LV-5417SLLC Riga Centre of Psychiatry and Narcology | Riga , Latvia, LV-1005SLLC Psychoneurological Hospital of Strenci | Strenči , Latvia, LV-4730State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital" | Arkhangelsk , Russia, 163530State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166 | Engel's , Russia, 413124State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow | Moscow , Russia, 117152State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5" | Moscow , Russia, 141371State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary | Saint Petersburg , Russia, 188820Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add | Saint Petersburg , Russia, 190005FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF | Saint Petersburg , Russia, 192019FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3 | Saint Petersburg , Russia, 192019Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov" | Saint Petersburg , Russia, 197341State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments | Saratov , Russia, 410028State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia | Saratov , Russia, 410060State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2" | Stavropol , Russia, 357034Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences", | Tomsk , Russia, 634014Clinic of Psychiatry, Clinical Center of Serbia, | Belgrade , Serbia, 11000Clinic of Psychiatry, Clinical Center of Serbia | Belgrade , Serbia, 11000Clinical Center "Dr Dragisa Misovic- Dedinje" | Belgrade , Serbia, 11000Special Hospital for Psychiatric Diseases "Kovin" | Kovin , Serbia, 26220Special Neuropsychiatric Hospital Kovin | Kovin , Serbia, 26220Clinic of Psychiatry, clinical Center Kragujevac | Kragujevac , Serbia, 34000University Clinical Center Kragujevac, Clinic of Psychiatry | Kragujevac , Serbia, 34000University Clinical Center Nis, Clinic of Psychiatry | Niš , Serbia, 18000Special Hospital for Psychiatric Disease Sveti Vracevi | Novi Kneževac , Serbia, 23330Special Hospital for Psychiatric Diseases "SVeti Vracevi" | Novi Kneževac , Serbia, 23330Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic" | Vršac , Serbia, 2630046 Academician Pavlov St | Kharkiv , Ukraine, 61068State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry | Kharkiv , Ukraine, 61068Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10 | Kherson , Ukraine, 73488Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology | Kyiv , Ukraine, 01030National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients | Kyiv , Ukraine, 01133Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2 | Kyiv , Ukraine, 08631Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 , | Kyiv , Ukraine, 08631Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 | Kyiv , Ukraine, 08631Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20 | Lviv , Ukraine, 79021Communal Institution O.I. Yuschenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio | Vinnytsia , Ukraine, 21005