A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
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
2 other identifiers
interventional
463
6 countries
58
Brief Summary
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 70 locations worldwide. The study will last up to 9 weeks total time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Sep 2019
Longer than P75 for phase_3 schizophrenia
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
September 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2023
CompletedJune 26, 2024
June 1, 2024
3.7 years
August 26, 2019
June 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline and Week 6
Secondary Outcomes (1)
Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)
Baseline and Week 6
Study Arms (3)
SEP-363856 50mg
EXPERIMENTALSEP-363856 50mg dosed once daily
SEP-363856 75mg
EXPERIMENTALSEP-363856 75mg dosed once daily
Placebo
PLACEBO COMPARATORPlacebo dosed once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Woodland International Research Group, LLC
Little Rock, Arkansas, 72211, United States
Advanced Research Center, Inc.
Anaheim, California, 92805, United States
CITrials
Bellflower, California, 90706, United States
Synergy San Diego
Lemon Grove, California, 91945, United States
Alliance for Research
Long Beach, California, 90807, United States
Catalina Research Institute
Montclair, California, 91763, United States
California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)
Pico Rivera, California, 90660, United States
UCSD Medical Center,UCSD Department of Psychiatry
San Diego, California, 92103-8229, United States
Larkin Behavioral Health Services
Hollywood, Florida, 33021, United States
Research Centers of America
Hollywood, Florida, 33024, United States
South Florida Research Phase I-IV, Inc.
Miami Springs, Florida, 33166, United States
Advanced Discovery Research LLC
Atlanta, Georgia, 30318, United States
Atlantic Center for Medical Research
Atlanta, Georgia, 30331, United States
iResearch Atlanta, LLC
Decatur, Georgia, 30030, United States
CBH Health, LLC
Gaithersburg, Maryland, 20877, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Community Clinical Research
Austin, Texas, 78754, United States
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, 4400, Bulgaria
UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic
Pleven, 5800, Bulgaria
Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders
Sofia, 1202, Bulgaria
UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry
Sofia, 1431, Bulgaria
UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry
Sofia, 1431, Bulgaria
Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders
Veliko Tarnovo, 5000, Bulgaria
Mental Health Center - Vratsa EOOD-Department of General Psychiatry
Vratsa, 3000, Bulgaria
E.S.E Hospital Mental de Antioquia - Unidad de Investigación
Bello, Antioquia, 051053, Colombia
Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda
Bogotá, 111166, Colombia
Centro 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, 454087, Russia
SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"
Moscow, 107076, Russia
State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod
Nizniy Novgorod, 603155, Russia
State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"
Petrozavodsk, 186131, Russia
FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12
Saint Petersburg, 092019, Russia
FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12
Saint Petersburg, 192019, Russia
State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"
Samara, 443016, Russia
State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents
Saratov, 410028, Russia
Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry
Belgrade, 11000, Serbia
Clinical Center Nis, Center of Mental Health Protection
Belgrade, 11000, Serbia
Institute of Mental Health
Belgrade, 11000, Serbia
Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39
Gornja Toponica, 18202, Serbia
Special Hospital for Psychiatric Diseases "Kovin",
Kovin, 26220, Serbia
Special Neuropsychiatric Hospital Kovin
Kovin, 26220, Serbia
Clinical Center Kragujevac, Clinic of Psychiatry
Kragujevac, 34000, Serbia
University Clinical Center Nis, Clinic of Psychiatry
Niš, 18000, Serbia
Special Hospital for Psychiatric Diseases "SVeti Vracevi",
Novi Kneževac, 23330, Serbia
Clinical Center of Vojvodina, Clinic of Psychiatry
Novi Sad, 21000, Serbia
Special Hospital for Psychiatric Diseases
Vršac, 26300, Serbia
15, Medychna St
Ivano-Frankivsk, 76011, Ukraine
2-A Metalurgiv st
Kropyvnytskyi, 25491, Ukraine
Dr. Vladyslav Demchenko
Kyiv, 02192, Ukraine
103 Kyrylivska St
Kyiv, 04080, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25
Lviv, 79021, Ukraine
9 Academician Vorobiov St
Odesa, 65006, Ukraine
1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region
Odesa, 67513, Ukraine
1 Medychna St
Poltava, 36013, Ukraine
Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
Smila, 20708, Ukraine
Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital
Vinnytsia, 21005, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
August 28, 2019
Study Start
September 11, 2019
Primary Completion
May 12, 2023
Study Completion
September 12, 2023
Last Updated
June 26, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.