Effects of Adjunctive Brexpiprazole in Major Depressive Disorder Analyzed by Baseline Anxiety Level: Post Hoc Analysis of a Phase 4 Study.

PURPOSE/

BACKGROUND

In 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/

RESULTS

One 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/

CONCLUSIONS

Over 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.