At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
ADT +1 moredrug
Likely dose
Not stated in 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 Phase 3b, Multicenter, Open-label Exploratory Trial to Evaluate the Efficacy, Safety, and Subject Satisfaction With Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Dec 16, 2013·Updated Dec 29, 2015
In Brief
A Phase 3 clinical trial evaluating ADT and Brexpiprazole for Major Depressive Disorder (MDD). Completed, enrolled 61 participants across 24 sites.
Detailed Summary
The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding adjunctive drug therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder (MDD)
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedDec 2013
Primary CompletionOct 2014
TodayJul 2026
First PostedDec 16, 2013
Enrollment StartNov 1, 2013
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.5 years ago
Interventions
ADTdrug
Brexpiprazoledrug