At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,182 enrolled
Drug / intervention
Brexpiprazole +2 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 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 16, 2012·Updated Jun 8, 2018
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole, Seroquel XR, and 1 other intervention for Depressive Disorder and 4 related conditions. Completed, enrolled 2,182 participants across 76 sites in 7 countries.
Detailed Summary
To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
CountriesCanada, France, Germany, Poland, Russia, Serbia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartDec 2012
Primary CompletionOct 2016
Study CompletionNov 2016
TodayJul 2026
First PostedNov 16, 2012
Enrollment StartDec 1, 2012
Primary CompletionOct 17, 2016
Study CompletionNov 10, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 13.6 years ago
Interventions
Brexpiprazoledrug
tablet/capsule
Seroquel XRdrug
tablet/capsule
Placebodrug
tablet/capsule