At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 48 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 3 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 331-13-003: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC 34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment.
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 17, 2013·Updated Mar 29, 2016
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for MDD. Completed, enrolled 48 participants across 24 sites.
Detailed Summary
To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response in a school or work environment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDD
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionSep 2014
Study CompletionOct 2014
TodayJul 2026
First PostedDec 17, 2013
Enrollment StartNov 1, 2013
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.5 years ago
Interventions
Brexpiprazoledrug
Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally