At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 38 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 2 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 331-13-009: An Exploratory, Multicenter, Randomized, Double-Blind, fMRI Study of Fixed-dose Brexpiprazole (OPC-34712) (2 and 4 mg/Day Tablets) in Adults With Schizophrenia With Impulsivity
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 21, 2014·Updated Nov 8, 2018
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Schizophrenia With Impulsivity. Completed, enrolled 38 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by impulsive behavior.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia With Impulsivity
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartFeb 2015
Primary CompletionApr 2016
TodayJul 2026
First PostedJul 21, 2014
Enrollment StartFeb 1, 2015
Primary CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago
Interventions
Brexpiprazoledrug
Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks