At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 97 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.
Protocol 331-13-008: An Exploratory, Multicenter, Open-label, Flexible-dose Brexpiprazole (OPC-34712) Trial in Adults With Acute Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Feb 4, 2014·Updated Dec 30, 2015
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Aripiprazole for Schizophrenia. Completed, enrolled 97 participants.
Detailed Summary
The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
Countries--
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedFeb 2014
Primary CompletionJun 2014
Study CompletionJul 2014
TodayJul 2026
First PostedFeb 4, 2014
Enrollment StartFeb 1, 2014
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.4 years ago
Interventions
Brexpiprazoledrug
Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally
Aripiprazoledrug
Up to 20 mg/day, once daily dose, tablets, orally