At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 837 enrolled
Drug / intervention
Placebo + ADT +1 moredrug
Likely dose
Brexpiprazole +ADT 2mgfrom 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 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 22, 2014·Updated Aug 21, 2018
In Brief
A Phase 3 clinical trial evaluating Placebo + ADT and Brexpiprazole +ADT for Depressive Disorder and 4 related conditions. Completed, enrolled 837 participants across 47 sites in 5 countries.
Detailed Summary
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
CountriesGermany, Hungary, Poland, Slovakia, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionApr 2016
Study CompletionMay 2016
TodayJul 2026
First PostedJul 22, 2014
Enrollment StartJul 1, 2014
Primary CompletionApr 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.9 years ago
Interventions
Placebo + ADTdrug
Placebo + ADT Placebo + FDA Approved Antidepressant (ADT)
Brexpiprazole +ADTdrug
Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)