Efficacy of Adjunctive Brexpiprazole in Patients With Unresolved Symptoms of Depression on Antidepressant Treatment Who Are Early in the Disease Course: a Post Hoc Analysis of Four Randomized Studies

Abstract: Background: Approximately 50% of patients with major depressive disorder (MDD) have unresolved symptoms of depression on antidepressant treatment (ADT). For such patients, early optimized treatment is critical. This pooled analysis investigated the efficacy of adjunctive brexpiprazole in patients with MDD and unresolved symptoms of depression, in subgroups indicative of early illness (i.e., younger age, fewer lifetime episodes, shorter episode duration, and fewer prior ADTs). Methods: Data were included from four randomized, double-blind, placebo-controlled studies of adjunctive brexpiprazole in adults with MDD and inadequate response to ADTs (i.e., persistent symptoms without substantial improvement) (NCT01360645, NCT01360632, NCT02196506, NCT01727726). The studies comprised an 8–10-week prospective phase during which all patients received ADT + placebo, followed by a 6-week randomized phase during which patients received either ADT + placebo or ADT + brexpiprazole. In this analysis, change from baseline in Montgomery–Åsberg Depression Rating Scale (MADRS) Total score was stratified by patients’ baseline age (