Impact of Adjunctive Cariprazine on Quality of Life in Major Depressive Disorder: A Post Hoc Analysis

This work was sponsored by AbbVie Objective: To evaluate the effects of cariprazine adjunctive to antidepressant therapy (ADT) on health-related quality of life (HRQoL) in patients with major depressive disorder (MDD). Methods: In a phase 3 clinical trial, adults with MDD and inadequate response to antidepressant monotherapy were randomized 1:1:1 to receive cariprazine 1.5 mg/d+ADT, cariprazine 3.0 mg/d+ADT, or placebo+ADT. Changes were evaluated from baseline to Week 6 in 12-item Short Form version 2 (SF-12v2) health survey mental component summary (MCS) and physical component summary (PCS) scores, with post hoc analysis evaluating SF-12v2 subdomain scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Higher scores indicated better HRQoL. Differences between cariprazine groups versus placebo in least squares mean (LSM) change from baseline to Week 6 were analyzed using ANCOVA. Results: The mITT population included 751 participants (cariprazine+ADT: 1.5 mg/d=250; 3.0 mg/d=252; placebo+ADT=249). MCS score increases were significantly greater for cariprazine 1.5 mg/d+ADT (LSM change=14.23; P=.0103 vs placebo) and 3.0 mg/d+ADT (LSM change=13.74; P=.0331 vs placebo) versus placebo+ADT (LSM change=11.43); PCS scores were numerically greater for both cariprazine groups versus placebo+ADT. LSM changes were significantly greater for cariprazine 1.5 mg/d+ADT versus placebo+ADT in social functioning and role-emotional subdomains and for each cariprazine group versus placebo in the mental health subdomain (each comparison, P<.05 vs="" placebo="" other="" subdomain="" scores="" were="" numerically="" greater="" in="" both="" cariprazine="" groups="" versus="" but="" differences="" non-significant.="" conclusion:="" adjunctive="" had="" significant="" positive="" effects="" on="" hrqol="" specifically="" sf-12v2="" mcs="" and="" social="" functioning="" role-emotional="" mental="" health="" subdomains.="">