CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 464 enrolled / 464 target
Drug / intervention
SEP-363856 75mg +2 moredrug
Likely dose
SEP-363856 75mgfrom 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.

Search/NCT04092686
NCT04092686Phase 3CompletedMonitor (5.8/mo)Completion was 36mo ago
CompareCT.gov

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 Sep 17, 2019·Updated Jun 18, 2026

In Brief

A Phase 3 clinical trial evaluating SEP-363856 75mg, SEP-363856 100mg, and 1 other intervention for Schizophrenia. Completed, enrolled 464 participants across 53 sites in 7 countries.

Signals

Enrolling slower than its timeline implies

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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Croatia, Latvia, Russia, Serbia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedSep 17, 2019
Enrollment StartOct 14, 2019
Primary CompletionJun 14, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.8 years ago

Arms & Interventions

SEP-363856 75mgexperimental

SEP-363856 75mg dosed once daily

Drug: SEP-363856 75mg
SEP-363856 100mgexperimental

SEP-363856 100mg dosed once daily

Drug: SEP-363856 100mg
Placeboplacebo_comparator

Placebo dosed once daily

Drug: Placebo

Interventions

SEP-363856 75mgdrug

SEP-363856 75mg tablet dosed once daily

SEP-363856 100mgdrug

SEP-363856 100mg tablet dosed once daily

Placebodrug

Placebo tablet dosed once daily