A Clinical Trial That Will 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
464
7 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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Oct 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
September 13, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2023
CompletedResults Posted
Study results publicly available
June 18, 2026
CompletedJune 18, 2026
May 1, 2026
3.7 years
September 13, 2019
May 26, 2026
May 26, 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 Score at Week 6
Baseline, Week 6
Study Arms (3)
SEP-363856 75mg
EXPERIMENTALSEP-363856 75mg dosed once daily
SEP-363856 100mg
EXPERIMENTALSEP-363856 100mg dosed once daily
Placebo
PLACEBO COMPARATORPlacebo dosed once daily
Interventions
Eligibility Criteria
You may qualify if:
- Male or female participant between 18 to 65 years of age (inclusive) at the time of consent.
- Participant must give written informed consent and privacy authorization prior to participation in the study.
- Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing.
- Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4.
- Participant must have a Positive and Negative Syndrome Scale (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.
- Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
- Participant has marked deterioration of functioning in one or more areas.
- Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values.
You may not qualify if:
- Participant is at significant risk of harming self, others, or objects based on Investigator's judgment.
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study
- Female participant who is pregnant or lactating
- Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Research Site
Rogers, Arkansas, 72758, United States
Research Site
Anaheim, California, 92805, United States
Research Site
Bellflower, California, 90706, United States
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Culver City, California, 90230, United States
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Long Beach, California, 90806, United States
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San Diego, California, 92102, United States
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Sherman Oaks, California, 91403, United States
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Hollywood, Florida, 33021, United States
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Miami Springs, Florida, 33166, United States
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Atlanta, Georgia, 30331, United States
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Decatur, Georgia, 30030, United States
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Chicago, Illinois, 60641, United States
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Lake Charles, Louisiana, 70629, United States
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Gaithersburg, Maryland, 20877, United States
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St Louis, Missouri, 63125, United States
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Marlton, New Jersey, 08053, United States
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New York, New York, 10032, United States
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Richardson, Texas, 75080, United States
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Burgas, 8000, Bulgaria
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Kardzhali, 6600, Bulgaria
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Novi Iskar, 1282, Bulgaria
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Plovdiv, 4000, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1431, Bulgaria
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Zagreb, 10090, Croatia
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Daugavpils, LV-5417, Latvia
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Riga, LV-1005, Latvia
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Strenči, LV-4730, Latvia
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Arkhangelsk, 163530, Russia
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Engel's, 413124, Russia
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Moscow, 117152, Russia
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Moscow, 141371, Russia
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Saint Petersburg, 188820, Russia
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Saint Petersburg, 190005, Russia
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Saint Petersburg, 192019, Russia
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Saint Petersburg, 197341, Russia
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Saratov, 410028, Russia
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Saratov, 410060, Russia
Research Site
Stavropol, 357034, Russia
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Tomsk, 634014, Russia
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Belgrade, 11000, Serbia
Research Site
Kovin, 26220, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Novi Kneževac, 23330, Serbia
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Vršac, 26300, Serbia
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Kharkiv, 61068, Ukraine
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Kherson, 73488, Ukraine
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Kyiv, 01030, Ukraine
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Kyiv, 01133, Ukraine
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Kyiv, 08631, Ukraine
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Lviv, 79021, 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
September 13, 2019
First Posted
September 17, 2019
Study Start
October 14, 2019
Primary Completion
June 14, 2023
Study Completion
June 14, 2023
Last Updated
June 18, 2026
Results First Posted
June 18, 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.