Effects of Adjunctive Brexpiprazole on Patient Life Engagement in Major Depressive Disorder Analyzed by Baseline Clinical Characteristics: Post Hoc analysis of a Phase 4, Open-Label Study

This work was sponsored by Otsuka Canada Pharmaceutical Inc. (Saint-Laurent, Quebec, Canada) and Lundbeck Canada Inc. (Saint-Laurent, Quebec, Canada) Patient life engagement describes positive health aspects across emotional, physical, social, and cognitive domains, which can be measured using the 10-item Inventory of Depressive Symptomatology Self-Report (IDS-SR10) Life Engagement subscale. This post hoc analysis evaluated if baseline depression characteristics, including functioning and anxiety symptoms, may influence the effect of adjunctive brexpiprazole on patient life engagement in patients with major depressive disorder (MDD). This is a post hoc analysis of a Phase 4, open-label, 8-week study of the effect of adjunctive brexpiprazole 0.5–2 mg/day on patient life engagement in adults with MDD and inadequate response to antidepressant treatment, conducted in Canada (NCT04830215; n=120 treated). In this analysis, patients were grouped by baseline scores: Patient Health Questionnaire-9 (PHQ-9) (≤19 versus >19), Patient Global Impression – Severity (≤4 versus >4), IDS-SR Total (≤38 versus >38), Clinical Global Impression – Severity (≤4 versus >4), Sheehan Disability Scale (≤6 versus >6), and Generalized Anxiety Disorder-7 (≤14 versus >14). Least squares (LS) mean change from baseline in IDS-SR10 Life Engagement score in each subgroup was examined. In all subgroups, mean IDS-SR10 score decreased from baseline to Week 8 (all p0.05). In patients with MDD, adjunctive brexpiprazole was associated with improvement over 8 weeks in patient life engagement across all studied subgroups, in patients with higher or lower severity of baseline depressive symptoms, functioning, and anxiety symptoms.