Cariprazine for the Adjunctive Treatment of Major Depressive Disorder: Results of a Randomized Phase 3 Placebo-Controlled Study (Study 301)

Abstract: Background: Patients with MDD often do not respond to antidepressant (ADT) monotherapy. Cariprazine (CAR) is under investigation as adjunctive therapy for patients with MDD. Methods: This randomized, double-blind, placebo (PBO)-controlled study assessed efficacy, safety, and tolerability of CAR 1.5 and 3 mg/d as an adjunct to ADT in patients with MDD and inadequate response to ADT alone. The primary endpoint was change from baseline to week 6 in MADRS total score. Results: Patients (n=751) in the modified intent-to-treat population were randomly assigned to CAR 1.5 mg/d+ADT (n=250), CAR 3 mg/d+ADT (n=252) or PBO+ADT (n=249). Mean age was 44.8 years, and 73.4% were female; mean baseline total scores were: MADRS=32.5. Difference in MADRS total score change from baseline to week 6 was statistically significant after multiplicity adjustment for CAR 1.5 mg/d vs PBO (-14.1 vs -11.5; adjusted P=.0050), but not for CAR 3 mg/d (-13.1; P=.0727). Differences for CAR 1.5 mg/d vs PBO were observed by week 2 (nominal P=.0453) and maintained at weeks 4 (nominal PShort Description: Cariprazine was assessed as an adjunctive treatment in adults with MDD who had an inadequate response to antidepressant (ADT) monotherapy: Cariprazine 1.5 mg/d was effective as adjunctive treatment and generally well tolerated with a safety profile consistent with other indications.Name of Sponsoring Organization(s): AbbVie