An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
1 other identifier
interventional
75
1 country
16
Brief Summary
An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Mar 2023
16 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
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 23, 2023
CompletedStudy Start
First participant enrolled
March 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2024
CompletedResults Posted
Study results publicly available
November 12, 2025
CompletedDecember 11, 2025
August 1, 2025
1.5 years
February 13, 2023
October 31, 2025
November 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants With Adverse Events (AEs)
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Number of Participants With Serious Adverse Events
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event is any AE occurring at any dose that results in death, is life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization, or is a congenital anomaly/birth defect.
From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Number of Participants With AEs Leading to Discontinuation of Study
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease occurring after the administration of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. AEs leading to discontinuation from the study are those AEs which caused participant to discontinue from the study.
From first dose of study drug up to end of 1 week follow up period (up to Week 25)
Study Arms (1)
SEP-363856
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject has given written informed consent and privacy authorization prior to participation in the study.
- Subject has completed the Treatment Period of Study SEP361-308.
- Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
- Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
You may not qualify if:
- Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
- Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
- Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
- Female subject is pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Research Site
Anaheim, California, 92805, United States
Research Site
Bellflower, California, 90706, United States
Research Site
Garden Grove, California, 92845, United States
Research Site
Lemon Grove, California, 91945, United States
Research Site
Santee, California, 92071, United States
Research Site
Torrance, California, 90502, United States
Research Site
Hollywood, Florida, 33021, United States
Research Site
Miami, Florida, 33122, United States
Research Site
Atlanta, Georgia, 30318, United States
Research Site
Atlanta, Georgia, 30331, United States
Research Site
Chicago, Illinois, 60640, United States
Research Site
Gaithersburg, Maryland, 20877, United States
Research Site
Berlin, New Jersey, 08009, United States
Research Site
Charlotte, North Carolina, 28211, United States
Research Site
Hickory, North Carolina, 28601, United States
Research Site
Richardson, Texas, 75080, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
February 23, 2023
Study Start
March 31, 2023
Primary Completion
September 23, 2024
Study Completion
September 23, 2024
Last Updated
December 11, 2025
Results First Posted
November 12, 2025
Record last verified: 2025-08
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. Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.