Effects of Adjunctive Brexpiprazole on Patient Life Engagement in Major Depressive Disorder: A Phase 4, Open-Label, Interventional Study

Abstract: Background: Patient life engagement is a broad term describing positive health aspects across four domains (emotional, physical, social, cognitive). The 10-item Inventory of Depressive Symptomatology Self-Report Life Engagement exploratory subscale (IDS-SR10) is a proposed measure of patient life engagement. Post hoc analyses suggest that brexpiprazole may improve patient life engagement when administered as adjunctive therapy to antidepressant treatment (ADT) in patients with major depressive disorder (MDD). This study is the first to prospectively evaluate the effect of adjunctive brexpiprazole on patient life engagement in MDD. Methods: This was a Phase 4, open-label, interventional study (NCT04830215). Adult outpatients were eligible if they had MDD and inadequate response to 1–2 ADTs (including current ADT) in the current episode. Following screening, eligible patients entered an 8-week, open-label treatment phase, during which they continued their current ADT, and initiated brexpiprazole 0.5–2 mg/day. The co-primary endpoints were change from baseline to Week 8 in IDS-SR10 Life Engagement score and in IDS-SR Total score. Safety and tolerability were also assessed. Results: The safety and efficacy samples comprised 120 patients. A statistically significant least squares mean change (improvement) was observed from baseline to Week 8 in IDS-SR10 Life Engagement score (-8.11 [standard error 0.62; 95% confidence interval -9.34, -6.88]; p