Trial reportJournal of clinical psychopharmacology
Effects of Adjunctive Brexpiprazole in Major Depressive Disorder Analyzed by Baseline Anxiety Level: Post Hoc Analysis of a Phase 4 Study.
Trial report in Journal of clinical psychopharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
PURPOSE/
backgroundIn patients with major depressive disorder (MDD), anxiety symptoms are common and associated with reduced treatment response. In an 8-week, phase 4, open-label study (ENGAGE), patients with MDD and inadequate antidepressant treatment response showed improvements in patient life engagement, depressive symptoms, and anxiety symptoms following treatment with adjunctive brexpiprazole 0.5 to 2 mg/d. This post hoc analysis of ENGAGE aimed to characterize the utility of adjunctive brexpiprazole in clinically relevant subgroups by baseline anxiety level. METHODS/PROCEDURES: Baseline anxiety subgroups were based on the 7-item Generalized Anxiety Disorder scale total score: no/mild (<10), moderate (10 to 14), and severe (>14). In each subgroup, changes in the 10-item Inventory of Symptomatology Self-Report (IDS-SR 10 ) Life Engagement subscale score, IDS-SR total score, and other efficacy outcomes were determined. Safety was also analyzed. FINDINGS/
resultsOne hundred twenty patients received adjunctive brexpiprazole, of whom 30 (25.0%) had no/mild anxiety, 43 (35.8%) had moderate anxiety, and 47 (39.2%) had severe anxiety at baseline. On IDS-SR 10 Life Engagement subscale score and IDS-SR total score, improvements (nominal P <0.001) from baseline to week 8 were observed across all subgroups. Improvements were also observed on all other efficacy endpoints (nominal P <0.05 in all subgroups). Incidence of treatment-emergent adverse events was 76.7% (no/mild baseline anxiety), 72.1% (moderate baseline anxiety), and 57.4% (severe baseline anxiety). No new safety signals were observed. IMPLICATIONS/
conclusionsOver 8 weeks, adjunctive brexpiprazole was associated with improvements in patient life engagement and depressive symptoms, regardless of baseline anxiety level. This observation may assist clinical decision-making when treating patients with MDD with/without anxiety symptoms.
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