At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 322 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 Multicenter, Randomized, Double-blind Trial of Brexpiprazole Versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Aug 23, 2017·Updated Feb 10, 2020
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Placebo for Bipolar I Disorder and Manic Episode. Completed, enrolled 322 participants across 48 sites in 4 countries.
Detailed Summary
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder, Manic Episode
CountriesBulgaria, Poland, Serbia, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionJan 2019
TodayJul 2026
First PostedAug 23, 2017
Enrollment StartSep 14, 2017
Primary CompletionJan 2, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.9 years ago
Interventions
Brexpiprazoledrug
Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.
Placebodrug
Administered orally daily for 3 weeks.