Overview of Short-Term and Long-Term Safety of Brexpiprazole in Patients with Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
J. Nelson, Peter Zhang, A. Skuban, M. Hobart, C. Weiss, E. Weiller, M. Thase
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引用次数: 20
Abstract
Background: Many patients with major depressive disorder (MDD) do not respond adequately to first-line antidepressant treatment (ADT). Adjunctive treatment with second-generation antipsychotics has demonstrated efficacy for patients with MDD, but is limited by tolerability and safety issues. The recently introduced serotonin-dopamine activity modulator, brexpiprazole, has demonstrated efficacy as an adjunctive treatment for MDD. Objective/Method: We report tolerability and safety results for adjunctive brexpiprazole from four 6-week short-term (ST; pooled phase 2 and 3, placebo-controlled) and two 52-week long-term (LT; pooled, openlabel) studies. Results: Approximately 90% of patients completed the ST studies, and 48.8% of patients completed the LT studies. In the ST studies, 2.9% of patients discontinued because of an adverse event (AE); in the LT studies, 14.1% of patients discontinued because of an AE. In the ST and LT studies, the most frequently reported treatment-emergent AEs (TEAEs) were akathisia (8.6% and 10.0%, respectively) and weight gain (7.3% and 25.5%, respectively). Rates of sedation and somnolence were low (ST and LT: sedation, 0.8% and 3.7%, respectively; somnolence, 3.4% and 9.4%, respectively). In the ST and LT studies, brexpiprazole was associated with small changes in metabolic parameters and moderate weight increase. Conclusions: Collectively, these data suggest brexpiprazole is well tolerated as an adjunctive treatment for MDD.
期刊介绍:
Current Psychiatry Reviews publishes frontier reviews on all the latest advances on clinical psychiatry and its related areas e.g. pharmacology, epidemiology, clinical care, and therapy. The journal’s aim is to publish the highest quality review articles dedicated to clinical research in the field. The journal is essential reading for all clinicians, psychiatrists and researchers in psychiatry.