At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 468 enrolled
Drug / intervention
Placebo +2 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.
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Placebo, Brexpiprazole, and 1 other intervention for Schizophrenia. Completed, enrolled 468 participants across 1 site.
Detailed Summary
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedMar 2013
Primary CompletionDec 2014
TodayJul 2026
First PostedMar 13, 2013
Enrollment StartMar 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.3 years ago
Interventions
Placebodrug
Once daily as tablets and capsules, orally
Brexpiprazoledrug
2-4 mg/day, once daily, tablets, orally
Quetiapine extended releasedrug
400-800 mg/day, once daily, encapsulated tablets, orally