Clinical Outcomes Among Patients Taking Brexpiprazole as Augmentation with Antidepressant Treatment for Major Depressive Disorder in a United States Real-World Dataset

Abstract

Efficacy of brexpiprazole as an adjunctive treatment to antidepressants for the treatment of major depressive disorder (MDD) has been demonstrated in several clinical trials. However, there is limited evidence on longer-term and real-world clinical effectiveness. The primary aim of this study was to characterize and evaluate clinical outcomes among patients with MDD treated with adjunctive brexpiprazole. This observational study examined outcomes among patients with MDD treated with brexpiprazole augmentation from a large United States real-world MDD dataset. The index date was the date of the first brexpiprazole prescription (written or filled) between July 10, 2015 and January 31, 2023. Patients with ≥ 2 MDD diagnoses before the index date, treatment with brexpiprazole for ≥ 30 days while on antidepressants; treatment with antidepressants for ≥ 60 days pre- and 30 days post-initiation, and with ≥ 1 9-item Patient Health Questionnaire (PHQ-9) score recorded 12 months pre- and post-index date were included. The primary outcome was improvement in depression symptoms as measured by the PHQ-9, together with PHQ-9 response (≥ 50% decrease in score) and remission (score < 5). Secondary outcomes assessed anxiety and overall clinical improvement. There were 1073 patients with MDD included in the final cohort. Mean PHQ-9 score decreased from baseline to follow-up (12.0 vs. 9.2; mean change − 2.8; 95% CI: − 3.1 to − 2.4; p < 0.001). PHQ-9 response was shown in 325 (30.3%) patients. The percentage of patients in PHQ-9 remission increased from baseline to follow-up (11.0% vs. 25.7%; p < 0.001). Anxiety and overall clinical status also improved. Findings suggest sustained clinical improvement among patients with MDD when antidepressant treatment was augmented with brexpiprazole. These findings are consistent with other studies of brexpiprazole.

The authors' abstract, as published at the source. Neurology and Therapy, 2026 · DOI ↗