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
53
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.
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
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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 17, 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
CompletedResults Posted
Study results publicly available
May 28, 2026
CompletedMay 28, 2026
May 1, 2026
3.7 years
August 26, 2019
May 4, 2026
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in PANSS Total Score at Week 6
PANSS was an interview-based assessment comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). The Positive subscale assessed hallucinations, delusions, and related symptoms; the Negative subscale assessed emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addressed other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicated the presence of progressively more severe symptoms, was used to score each item. Individual items were then summed to determine scores for the 3 subscales, as well as a total score. PANSS total score ranges from: 30-210, where a higher score indicates greater severity. A negative change from baseline indicates improvement.
Baseline, Week 6
Secondary Outcomes (1)
Change From Baseline in CGI-S Total Score at Week 6
Baseline, 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 (53)
Research Site
Little Rock, Arkansas, 72211, United States
Research Site
Anaheim, California, 92805, United States
Research Site
Bellflower, California, 90706, United States
Research Site
Lemon Grove, California, 91945, United States
Research Site
Long Beach, California, 90807, United States
Research Site
Montclair, California, 91763, United States
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Pico Rivera, California, 90660, United States
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San Diego, California, 92103, United States
Research Site
Hollywood, Florida, 33021, United States
Research Site
Hollywood, Florida, 33024, United States
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Miami Springs, Florida, 33166, United States
Research Site
Atlanta, Georgia, 30318, United States
Research Site
Atlanta, Georgia, 30331, United States
Research Site
Decatur, Georgia, 30030, United States
Research Site
Gaithersburg, Maryland, 20877, United States
Research Site
Flowood, Mississippi, 39232, United States
Research Site
Dayton, Ohio, 45417, United States
Research Site
Austin, Texas, 78754, United States
Research Site
Pazardzhik, 4400, Bulgaria
Research Site
Pleven, 5800, Bulgaria
Research Site
Sofia, 1202, Bulgaria
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Sofia, 1431, Bulgaria
Research Site
Veliko Tarnovo, 5000, Bulgaria
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Vratsa, 3000, Bulgaria
Research Site
Bello, Antioquia, 051053, Colombia
Research Site
Bogotá, 111166, Colombia
Research Site
Bogotá, Colombia
Research Site
Chelyabinsk, 454087, Russia
Research Site
Moscow, 107076, Russia
Research Site
Nizniy Novgorod, 603155, Russia
Research Site
Petrozavodsk, 186131, Russia
Research Site
Saint Petersburg, 092019, Russia
Research Site
Saint Petersburg, 192019, Russia
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Samara, 443016, Russia
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Saratov, 410028, Russia
Research Site
Belgrade, 11000, Serbia
Research Site
Gornja Toponica, 18202, Serbia
Research Site
Kovin, 26220, Serbia
Research Site
Kragujevac, 34000, Serbia
Research Site
Niš, 18000, Serbia
Research Site
Novi Kneževac, 23330, Serbia
Research Site
Novi Sad, 21000, Serbia
Research Site
Vršac, 26300, Serbia
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Ivano-Frankivsk, 76011, Ukraine
Research Site
Kropyvnytskyi, 25491, Ukraine
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Kyiv, 02192, Ukraine
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Kyiv, 04080, Ukraine
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Lviv, 79021, Ukraine
Research Site
Odesa, 65006, Ukraine
Research Site
Odesa, 67513, Ukraine
Research Site
Poltava, 36013, Ukraine
Research Site
Smila, 20708, Ukraine
Research Site
Vinnytsia, 21005, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Otsuka
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
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 17, 2019
Primary Completion
May 12, 2023
Study Completion
September 12, 2023
Last Updated
May 28, 2026
Results First Posted
May 28, 2026
Record last verified: 2026-05
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.