The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial

Abstract

Abstract Introduction Individuals with bipolar depression often experience functional impairment that interferes with recovery. These analyses examined the effects of cariprazine on functional outcomes in patients with bipolar I disorder. Methods Prespecified analyses of data from a randomized, double-blind, placebo-controlled pivotal trial of cariprazine in bipolar I depression (NCT01396447) evaluated mean changes from baseline to week 8 in Functional Assessment Short Test (FAST) total score. Post hoc analyses with no adjustment for multiplicity evaluated FAST subscale scores, functional recovery and remission (FAST total score ≤11 and ≤20, respectively), and 30% or 50% improvement from baseline. Results There were 393 patients with bipolar I disorder (placebo = 132; cariprazine: 1.5\u2009mg/d\u2009=\u2009135, 3\u2009mg/d\u2009=\u2009126) in the FAST analysis population. Statistically significant differences were noted for cariprazine 1.5\u2009mg/d versus placebo in mean change from baseline in FAST total score (p<.01) and on 5 of 6 subscale scores (p<.05); cariprazine 3\u2009mg/d was significantly different than placebo on the Interpersonal Relationship subscale (p<.05). Rates of functional remission and recovery, and ≥30% or ≥50% improvement were significantly greater for cariprazine 1.5\u2009mg/d versus placebo (p<.05 all); the percentage of patients with ≥30% improvement was significantly different for cariprazine 3\u2009mg/d versus placebo (p<.05). Conclusion At week 8, statistically significant improvements in FAST outcomes were observed for cariprazine versus placebo in patients with bipolar I depression; more consistent results were noted for 1.5\u2009mg/d than 3\u2009mg/d. In addition to improving bipolar depression symptoms, these results suggest that cariprazine may improve functional outcomes.