At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 101 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 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 28, 2022·Updated Dec 11, 2025
In Brief
A Phase 3 clinical trial evaluating SEP-363856 for Schizophrenia. Completed, enrolled 101 participants across 25 sites.
Detailed Summary
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedNov 2022
Enrollment StartDec 2022
Primary CompletionApr 2024
TodayJul 2026
First PostedNov 28, 2022
Enrollment StartDec 19, 2022
Primary CompletionApr 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.6 years ago
Interventions
SEP-363856drug
SEP-363856 flexibly dosed for 8 weeks.