Adjunctive Brexpiprazole in Patients With Major Depressive Disorder Who Had One Prior Inadequate Antidepressant Including in a Subgroup With Energy/Concentration Symptoms

This work was sponsored by Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and Lundbeck LLC (Deerfield, IL, USA). Many patients with major depressive disorder (MDD) experience unresolved depressive symptoms following antidepressant treatment (ADT), including energy and concentration issues. Early optimized treatment increases the likelihood of recovery. This post hoc analysis explored the efficacy of adjunctive brexpiprazole in patients with MDD who had received, and demonstrated inadequate response to, only one prior ADT in the current episode, including in a subgroup with baseline energy and concentration symptoms. Data were pooled from three fixed-dose studies of adjunctive brexpiprazole in adults with MDD. Patients with inadequate response to ADT were randomized to ADT + placebo or ADT + brexpiprazole. The primary endpoint in each study was the change from baseline to Week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total score. Presence of baseline energy and concentration symptoms was defined as a score ≥1 on Inventory of Depressive Symptomatology – Self-Report items 15 (Concentration/decision making), 20 (Energy level), 23 (Feeling slowed down) and 30 (Leaden paralysis/physical energy). In the analyzed sample, the change at Week 6 in MADRS Total score was -8.9 (ADT + brexpiprazole 2–3 mg) versus -6.7 (ADT + placebo) (p