Effect of Adjunctive Cariprazine on Symptoms of Anhedonia in Patients with Major Depressive Disorder

This work was sponsored by AbbVie Background: Post-hoc analysis evaluating efficacy of adjunctive cariprazine (CAR) treatment on anhedonia symptoms in patients with major depressive disorder (MDD). Methods: Patients with MDD and inadequate response to ongoing antidepressant therapy (ADT) were randomized to CAR 1.5mg/d+ADT, CAR 3mg/d+ADT, or placebo+ADT for 6-weeks of double-blind treatment. Post-hoc analyses evaluated change from baseline to Week-6 in Montgomery–Åsberg Depression Rating Scale (MADRS) total score, MADRS anhedonia subscale, and MADRS anhedonia item-8 [inability to feel] in modified intent-to-treat (mITT) population, patients with baseline MADRS anhedonia item-8 score of ≥4, or baseline anhedonia subscale score of ≥18. Results: 751 patients in mITT population (CAR+ADT: 1.5mg/d=250, 3mg/d=252; placebo+ADT=249). At baseline, 508 (67.6%) patients had MADRS anhedonia item-8 scores ≥4, and 584 (77.8%) had MADRS anhedonia subscale scores ≥18. In mITT population, LS mean change from baseline to Week-6 in anhedonia subscale score was greater for CAR 1.5mg/d+ADT (-8.4) and 3mg/d+ADT (-7.9) than for placebo+ADT (-6.8; both P<.05 ls="" mean="" change="" from="" baseline="" in="" madrs="" individual="" item-8="" was="" greater="" for="" car="" vs="" placebo="" adt="" p=".0085)." both="" subgroups="" with="" anhedonia:="" associated="" reduction="" total="" score="" anhedonia="" subscale="" and="" compared="" group:="" reductions="" observed="" patients="" scores="" conclusions:="" results="" suggest="" adjunctive="" treatment="" may="" be="" effective="" improving="" symptoms="" of="" mdd.="">