Study data published in the Journal of Clinical Psychiatry support the efficacy and tolerability of brexpiprazole as adjunctive therapy in patients with major depressive disorder.

Outpatients with a current major depressive episode and an inadequate response to 1 to 3 antidepressant treatments were randomly assigned to double-blind adjunctive brexpiprazole at 2 mg/d or placebo ( identifier: NCT02196506). Change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale and Sheehan Disability Scale scores were used as primary and secondary efficacy measures, respectively. Researchers also captured brexpiprazole tolerability through the record of adverse events and discontinuations.

According to the primary efficacy measure, improvement was significantly greater in the brexpiprazole group (n=191) compared with the placebo group (n=202) (P =.0074). Adjunctive brexpiprazole also improved depression scores in the patient subgroups with minimal response to prospective antidepressant therapy (P =.026) and anxious distress (P =.0099) compared with placebo. However, no statistically significant differences were observed between treatment methods on the Sheehan Disability Scale. More patients in the brexpiprazole group (59.9%) experienced treatment-emergent adverse events than in the placebo group (49.5%). The most commonly reported adverse events in patients receiving brexpiprazole were akathisia (8.3%), restlessness (8.3%), upper respiratory tract infection (5.2%), and increased weight. However, suicidal ideation was lower in the brexpiprazole group (3.6%) than in the placebo group (7.4%).

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These results support the efficacy and tolerability of adjunct brexpiprazole in treating depressive symptoms. Clinicians may find these data useful in treating patients with major depressive disorder and an inadequate response to antidepressant treatment alone.

Disclosures: Drs Hobart, Skuban, Zhang, Sanchez, and McQuade and Ms Augustine and Ms Brewer are employees of Otsuka Pharmaceutical Development & Commercialization Inc. Mr Hefting is an employee of H. Lundbeck A/S.

Funding/support: This study was developed by Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, and H. Lundbeck A/S, Valby, Denmark.


Hobart M, Skuban A, Zhang P, et al. A randomized, placebo-controlled study of the efficacy and safety of fixed-dose brexpiprazole 2 mg/d as adjunctive treatment of adults with major depressive disorder. J Clin Psychiatry. 2018;79(4):17m12058.