Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: post hoc analyses of three placebo-controlled studies

Michael E Thase,1 Emmanuelle Weiller,2 Peter Zhang,3 Catherine Weiss,4 Roger S McIntyre5 1Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, PA, USA; 2Medical Affairs, H. Lundbeck A/S, Valby, Copenhagen, Denmark; 3Biostatistics Department, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, USA; 4Global Medical Affairs, Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, USA; 5Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, Toronto, ON, Canada Objective: Episodes of major depressive disorder (MDD) characterized by high levels of anxiety symptoms are less likely to respond to some forms of antidepressant treatment (ADT). This report examines the effects of adjunctive brexpiprazole on depressive symptoms among patients with MDD and anxiety symptoms.Materials and methods: This was a post hoc analysis of 1,171 patients from the 6-week, randomized, double-blind phases of three studies in adults with MDD and inadequate response to ADTs (NCT01360645, NCT01360632, NCT02196506). Data were pooled for brexpiprazole 2–3 mg/day and for placebo (adjunct to ADT). Montgomery–Åsberg Depression Rating Scale Total score changes were assessed in subgroups of patients with and without anxious distress (based on proxies for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria) and anxious depression (defined as a Hamilton Depression Rating Scale Anxiety/somatization factor score of ≥7). Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs).Results: Benefits were seen for adjunctive brexpiprazole (compared with adjunctive placebo) in both anxiety definition subgroups. For patients with anxious distress, the least squares mean difference (95% CI) at week 6 was -3.00 (-4.29, -1.71; P<0.0001) and, for those without anxious distress, was -1.38 (-2.71, -0.05; P=0.043). For patients with anxious depression, the difference was -2.19 (-3.60, -0.78; P=0.0023), compared with -2.34 (-3.58, -1.10; P=0.0002) for those without anxious depression. The most common TEAEs among patients with anxiety symptoms receiving ADT + brexpiprazole were akathisia, headache, restlessness, somnolence, and weight increase. There were no clinically meaningful differences in the rates of these TEAEs according to the presence or absence of anxiety symptoms.Conclusion: Adjunctive brexpiprazole 2–3 mg/day may be efficacious in reducing depressive symptoms, and was well tolerated, in patients with clinically relevant anxiety symptoms. Keywords: depression, double-blind method, random allocation, antidepressants, antipsychotics

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