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Original Research

Adjunctive Brexpiprazole in Patients With Major Depressive Disorder and Irritability: An Exploratory Study

Maurizio Fava, MD; François Ménard, MD; Charlotte Kampp Davidsen, MSc; and Ross A. Baker, PhD, MBA

Published: December 28, 2016

Article Abstract

Objective: To evaluate the effects of adjunctive brexpiprazole on symptoms of irritability in patients with major depressive disorder (MDD).

Methods: Patients diagnosed with MDD according to DSM-IV-TR criteria who had inadequate response to antidepressant treatment continued treatment with their current antidepressant for 2 weeks. Patients still having inadequate response, and with irritability, received 6 weeks of open-label treatment with their current antidepressant at the same dose and adjunctive brexpiprazole (target dose: 3 mg/d). Brexpiprazole was discontinued at week 6, and the patients continued with their antidepressant until week 10. Changes from baseline to week 6 and week 6 to week 10 were analyzed.

Results: This study was conducted between October 7, 2013, and July 30, 2014. Fifty-four patients were treated with adjunctive brexpiprazole. At week 6, clinically relevant improvements were observed in Sheehan Irritability Scale total (21.1) and item 1 (irritable mood) (3.5) scores, Kellner Symptom Questionnaire total (24.4) and anger-hostility subscale (7.7) scores, and 30-item Inventory of Depressive Symptomatology, clinician version (IDS-C30), item 6 (irritable mood) score (1.2). More (15 patients) stopped than developed (5 patients) anger attacks during treatment, as measured by the Anger Attacks Questionnaire. The Clinical Global Impressions-Severity of Illness score improved (1.4), as did the depressive symptoms (IDS-C30 total score, 17.8; Kellner Symptom Questionnaire depression subscale score, 7.7; and Montgomery-Asberg Depression Rating Scale total score, 14.2). Irritability symptoms worsened after brexpiprazole discontinuation, assessed at week 10. Adjunctive brexpiprazole was well tolerated.

Conclusions: Adjunctive treatment with brexpiprazole may represent a strategy for patients with MDD and inadequate response to antidepressant treatment who have symptoms of irritability.

Trials Registration: identifier: NCT01942785

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