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Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: an exploratory study.

ABSTRACT: BACKGROUND:Major 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). METHODS:Patients 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). RESULTS:Of 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%). CONCLUSIONS:These open-label results support the anxiolytic effects of adjunctive brexpiprazole in the treatment of patients with MDD.

SUBMITTER: Davis LL

PROVIDER: S-EPMC5064333 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: an exploratory study.

Davis Lori L LL Ota Ai A Perry Pamela P Tsuneyoshi Kana K Weiller Emmanuelle E Baker Ross A RA

Brain and behavior 20160724 10

<h4>Background</h4>Major 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-HT<sub>1A</sub> and dopamine D<sub>2</sub> receptors at similar potency, and an antagonist at 5-HT<sub>2A</sub> and noradrenaline alpha<sub>1B/2C</sub> receptors. The objective of this Phase IIIb study was to explore effectiveness, safety, and tolerability of brexpiprazole adjunctive to antide ...[more]

PMID: 27781135

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Project description:ObjectiveEpisodes 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 methodsThis 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).ResultsBenefits 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.ConclusionAdjunctive brexpiprazole 2-3 mg/day may be efficacious in reducing depressive symptoms, and was well tolerated, in patients with clinically relevant anxiety symptoms.

Project description:BackgroundWe investigated the efficacy of electroconvulsive therapy in patients with major depressive disorder and concomitant anxiety symptoms and explored the relationships between depression symptoms and anxiety symptoms during acute electroconvulsive therapy.MethodsMajor depressive disorder inpatients (N = 130) requiring electroconvulsive therapy were recruited for a maximum of 12 treatments each. Depression symptoms, using the core factor subscale derived from the 17-item Hamilton Depression Rating Scale, and anxiety symptoms, using the anxiety/somatization subscale from the Hamilton Depression Rating Scale-17, were assessed before electroconvulsive therapy, after every 3 electroconvulsive therapy treatments, and after the final electroconvulsive therapy. Both core factor subscale and anxiety/somatization subscale scores were converted to T-score units to compare the degrees of changes between depression symptoms and anxiety symptoms after electroconvulsive therapy. The relationships between core factor subscale and anxiety/somatization subscale were analyzed using the cross-lagged longitudinal model during acute electroconvulsive therapy.ResultsA total 116 patients who completed at least the first 3 electroconvulsive therapy treatments were included in the analysis. Reduction of core factor scale T-scores was significantly greater than that of anxiety/somatization subscale T-scores. The model satisfied all indices of goodness-of-fit (chi-square = 30.204, df = 24, P = 0.178, Tucker-Lewis Index = 0.976, Comparative Fit Index = 0.989, Root Mean Square Error of Approximation = 0.047). Core factor subscale changes did not definitely predict subsequent anxiety/somatization subscale changes.ConclusionsElectroconvulsive therapy is effective in the acute treatment of major depressive disorder patients associated with anxiety symptoms. Anxiety symptoms improved less than depression symptoms during acute electroconvulsive therapy. However, earlier reduction in depression symptoms does not definitely drive subsequent relief in anxiety symptoms.

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Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: an exploratory study.

Publications

Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: an exploratory study.

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