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

摘要

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 = 30% or >= 50% improvement were significantly greater for cariprazine 1.5 mg/d versus placebo (p = 30% improvement was significantly different for cariprazine 3 mg/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 mg/d than 3 mg/d. In addition to improving bipolar depression symptoms, these results suggest that cariprazine may improve functional outcomes.