At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 75 enrolled
Drug / intervention
SEP-363856drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Feb 23, 2023·Updated Dec 11, 2025
In Brief
A Phase 3 clinical trial evaluating SEP-363856 for Schizophrenia. Completed, enrolled 75 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedFeb 2023
Enrollment StartMar 2023
Primary CompletionSep 2024
TodayJul 2026
First PostedFeb 23, 2023
Enrollment StartMar 31, 2023
Primary CompletionSep 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 3.4 years ago
Interventions
SEP-363856drug
SEP-363856 tablet