At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 740 enrolled
Drug / intervention
Brexpiprazole +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 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial to Assess the Efficacy and Safety of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole and Placebo for Major Depressive Disorder. Completed, enrolled 740 participants across 1 site.
Detailed Summary
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartJul 2018
First PostedOct 2018
Primary CompletionJun 2022
Study CompletionJul 2022
TodayJul 2026
First PostedOct 5, 2018
Enrollment StartJul 30, 2018
Primary CompletionJun 6, 2022
Study CompletionJul 4, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 7.7 years ago
Interventions
Brexpiprazoledrug
Tablets, Oral, once daily, 14 weeks
Placebodrug
Tablets, Oral, once daily, 14 weeks