At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 524 enrolled
Drug / intervention
Brexpiprazole +1 moredrug
Likely dose
Brexpiprazole 4 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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 20, 2012·Updated Jan 13, 2017
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Placebo for Acute Schizophrenia. Completed, enrolled 524 participants across 49 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Schizophrenia
CountriesColombia, Malaysia, Puerto Rico, Romania, Serbia, Turkey (Türkiye), Ukraine, United States
CollaboratorsQuintiles, Inc.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartOct 2012
Primary CompletionJan 2015
Study CompletionFeb 2015
TodayJul 2026
First PostedAug 20, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2015
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.9 years ago
Interventions
Brexpiprazoledrug
Brexpiprazole tablets 1 to 4 mg /day
Placebodrug
Placebo comparator for 52 weeks