CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 305 enrolled
Drug / intervention
SEP363856 +1 moredrug
Likely dose
SEP363856 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.

Search/NCT04115319
NCT04115319Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Oct 4, 2019·Updated Dec 31, 2025

In Brief

A Phase 3 clinical trial evaluating SEP363856 and quetiapine XR for Schizophrenia. Completed, enrolled 305 participants across 42 sites in 4 countries.

Detailed Summary

A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia. This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesRomania, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 4, 2019
Enrollment StartNov 21, 2019
Primary CompletionDec 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.7 years ago

Interventions

SEP363856drug

SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule

quetiapine XRdrug

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule