At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,986 enrolled
Drug / intervention
Placebo +2 moredrug
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.
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Long-term Study to Evaluate the Maintenance of Efficacy and Safety of 1 to 3 mg/Day of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
In Brief
A Phase 3 clinical trial evaluating Placebo, Brexpiprazole, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 1,986 participants across 107 sites in 16 countries.
Detailed Summary
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesBulgaria, Canada, Estonia, Finland, Germany, Latvia, Lithuania, Mexico, Poland, Romania, Russia, South Korea, Sweden, Ukraine, United Kingdom, United States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 2013
Enrollment StartJun 2013
Primary CompletionJun 2016
TodayJul 2026
First PostedApr 24, 2013
Enrollment StartJun 1, 2013
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.2 years ago
Interventions
Placebodrug
Once daily, tablets, orally
Brexpiprazoledrug
1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day
ADTdrug
Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label