At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 245 enrolled
Drug / intervention
SEP-363856 +1 moredrug
Likely dose
SEP-363856 50 mgfrom 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 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 21, 2016·Updated Jul 5, 2024
In Brief
A Phase 2 clinical trial evaluating SEP-363856 and Placebo - Cap for Schizophrenia. Completed, enrolled 245 participants across 33 sites in 5 countries.
Detailed Summary
A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesHungary, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionJul 2018
TodayJul 2026
First PostedNov 21, 2016
Enrollment StartDec 5, 2016
Primary CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.6 years ago
Interventions
SEP-363856drug
One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks
Placebo - Capdrug
One Placebo capsule daily for 4 weeks