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Brexpiprazole as Adjunctive Therapy in Maintenance Treatment of MDD
NCT03538691Phase 3
Key facts
- Status
- Completed
- Start
- Jul 2018
- Primary completion
- Jul 2022
- Countries
- 1
- Modality
- Small Molecules
- Conditions
- major depressive disorder (MDD)
01
Overview
Phase 3, randomised, double-blind trial of brexpiprazole orally disintegrating tablet in major depressive disorder (MDD) (2 arms), sponsored by Otsuka Pharmaceutical Development & Commercialization. Primary endpoint: Time-to-Relapse by Any Criteria at 28 weeks. Started Jul 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Brexpiprazole Maintenance
Continued Brexpiprazole + ADT
Placebo Withdrawal
Placebo + ADT
03
Who it enrols
Adults with recurrent Major Depressive Disorder in a current episode of at least 8 weeks duration, with an inadequate response to 1-2 antidepressant treatments.
04
Endpoints
Primary
Time-to-Relapse by Any Criteria
Secondary
Sheehan Disability Scale Mean Total Score
Time-to-functional Relapse Based on SDS Criteria
Percentage of Participants Meeting Any Relapse Criteria
Percentage of Participants Maintaining Remission
Montgomery-Asberg Depression Rating Scale Total Score
Clinical Global Impression-Severity Score
05
Results
Not all primary endpoints met
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