A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder

Phase 3 Completed 1149 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

Major depressive disorder (MDD) is a serious medical illness associated with significant suicidal risk and marked disability. Despite the availability of numerous treatments, achievement of consistent and favorable long-term outcomes remains challenging. This study will assess the safety, efficacy and tolerability of brexpiprazole as adjunctive therapy to protocol-specific open-label antidepressant therapy.

Timeline

Start: 2018-07-13
Primary completion: 2022-07-08
Completion: 2022-07-29

Outcome

Missed primary endpoint

registry Phase C: Brexpiprazole + ADT vs Phase C: Placebo + ADT; p = 0.5100; Hazard Ratio (HR) 1.138 (95% CI 0.776 to 1.669); Log Rank NCT03538691 ↗

Publications

McIntyre RS, Sundararajan K, Behl S, Hefting N, Jin N, Brewer C, Hobart M, Thase ME. A double-blind, placebo-controlled, randomised withdrawal study of adjunctive brexpiprazole maintenance treatment for major depressive disorder. Acta Neuropsychiatr. 2024 Oct 17;37:e33. doi: 10.1017/neu.2024.32.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	2 mg	Oral
Subject	Brexpiprazole	Small molecule	3 mg	Oral
Background	Citalopram	Small molecule	—	Oral
Background	Duloxetine	Small molecule	—	Oral
Background	Escitalopram	Small molecule	—	Oral
Background	Fluoxetine	Small molecule	—	Oral
Background	Paroxetine	Small molecule	—	Oral
Background	Sertraline	Small molecule	—	Oral
Background	Venlafaxine XR	Unknown	—	Oral