Abstract
BackgroundMajor depressive disorder (MDD) with concurrent anxiety symptoms may signal a difficult‐to‐treat patient. Brexpiprazole is a serotonin–dopamine activity modulator: a partial agonist at 5‐HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5‐HT2A and noradrenaline alpha1B/2C receptors. The objective of this Phase IIIb study was to explore effectiveness, safety, and tolerability of brexpiprazole adjunctive to antidepressant (ADT) monotherapy in patients with MDD and anxiety symptoms (NCT02013531).MethodsPatients with MDD, Hamilton Anxiety Rating Scale (HAM‐A) total score ≥ 20, and inadequate response to current ADT received open‐label brexpiprazole 1–3 mg day−1 (target dose 2 mg day−1) + ADT for 6 weeks. Efficacy endpoints included change from baseline at Week 6 in Montgomery–Åsberg Depression Rating Scale (MADRS) total score, HAM‐A total score, and Sheehan Disability Scale (SDS). Safety and tolerability assessments included adverse events (AEs).ResultsOf 37 participants enrolled, 32 (86.5%) completed the study. Baseline mean (SD) MADRS total score was 30.1 (5.1); mean HAM‐A total score was 26.9 (5.0). Improvements from baseline were observed at Week 6 for least squares mean change in MADRS total score (−19.6, p < .0001 vs. baseline), HAM‐A total score (−17.8, p < .0001) and mean (SD) SDS mean score [−3.6 (2.6)]. Brexpiprazole was well tolerated. The most frequent treatment‐emergent AEs were increased appetite (13.5%) and diarrhea, dry mouth, and dizziness (all 10.8%).ConclusionsThese open‐label results support the anxiolytic effects of adjunctive brexpiprazole in the treatment of patients with MDD.
Highlights
Anxiety symptoms are common in patients with major depressive disorder (MDD) (Fava et al, 2000; Zimmerman, McDermut, & Mattia, 2000)
Many studies have shown that anxiety symptoms in patients with Major depressive disorder (MDD) are associated with more severe depression, poorer course, greater impairment in functioning, and worse health-related quality of life (Fichter et al, 2010; Rhebergen et al, 2011; Wiethoff et al, 2010; Zimmerman et al, 2014), suggesting that anxiety symptoms in MDD are an indicator for more difficult-to-treat patients
Pooled analysis from two double-blind, placebo-controlled studies in patients with MDD and inadequate response to antidepressant treatments (ADTs) demonstrated that augmentation with aripiprazole improved Montgomery–Åsberg Depression Rating Scale (MADRS) total score in a subgroup with baseline Hamilton Rating Scale for Depression (HAM-D) anxiety/somatization factor score ≥ 7 (Trivedi et al, 2008)
Summary
Anxiety symptoms are common in patients with major depressive disorder (MDD) (Fava et al, 2000; Zimmerman, McDermut, & Mattia, 2000). Quetiapine extended-release (XR) augmentation has been reported to improve MADRS total score in subgroups of patients with MDD and inadequate response to ADTs, with anxious depression defined as baseline HAM-D anxiety/somatization factor score ≥ 7, and alternatively as baseline Hamilton Rating Scale for Anxiety (HAM-A) ≥ 20 (Bandelow et al, 2014). Brexpiprazole is a serotonin–dopamine activity modulator: a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors The objective of this Phase IIIb study was to explore effectiveness, safety, and tolerability of brexpiprazole adjunctive to antidepressant (ADT) monotherapy in patients with MDD and anxiety symptoms (NCT02013531). Conclusions: These open-label results support the anxiolytic effects of adjunctive brexpiprazole in the treatment of patients with MDD
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