At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 37 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 3mgfrom 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 331-13-002: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 17, 2013·Updated Mar 29, 2016
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Major Depressive Disorder and Anxiety. Completed, enrolled 37 participants across 21 sites.
Detailed Summary
The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Anxiety
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionMay 2014
Study CompletionJun 2014
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartNov 1, 2013
Primary CompletionMay 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.5 years ago
Interventions
Brexpiprazoledrug
Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally