At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 463 enrolled
Drug / intervention
SEP-363856 50mg +2 moredrug
Likely dose
SEP-363856 50mgfrom 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.
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
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 28, 2019·Updated May 28, 2026
In Brief
A Phase 3 clinical trial evaluating SEP-363856 50mg, SEP-363856 75mg, and 1 other intervention for Schizophrenia. Completed, enrolled 463 participants across 53 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Colombia, Russia, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2019
Primary CompletionMay 2023
Study CompletionSep 2023
TodayJul 2026
First PostedAug 28, 2019
Enrollment StartSep 17, 2019
Primary CompletionMay 12, 2023
Study CompletionSep 12, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.8 years ago
Interventions
SEP-363856 50mgdrug
SEP-363856 50mg tablet dosed once daily
SEP-363856 75mgdrug
SEP-363856 75mg tablet dosed once daily
Placebodrug
Placebo tablet dosed once daily