At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 248 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 2 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.
A Multi-center, Open-label Trial to Assess the Long-term Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Major Depressive Disorder. Completed, enrolled 248 participants across 1 site.
Detailed Summary
This trial is a 52-week study to assess the safety of long-term use of brexpiprazole as adjunctive therapy in combination with an antidepressant.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
Enrollment StartOct 2018
First PostedNov 2018
Primary CompletionMar 2021
Study CompletionApr 2021
TodayJul 2026
First PostedNov 9, 2018
Enrollment StartOct 4, 2018
Primary CompletionMar 17, 2021
Study CompletionApr 13, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.6 years ago
Interventions
Brexpiprazoledrug
2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily