Efficacy of Cariprazine in Patient Subgroups: Post Hoc Analysis of 3 Randomized, Placebo-Controlled Trials in Patients With Bipolar Depression
Introduction: Cariprazine is a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist approved to treat bipolar depression. The efficacy of cariprazine in patients with bipolar depression was evaluated in subgroups defined by baseline characteristics.
Methods: Data from patients in 3 cariprazine bipolar depression trials (NCT01396447, NCT02670538, NCT02670551) were categorized by baseline demographic and clinical variables and evaluated in post hoc analyses. Mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score was analyzed in a combined cariprazine
1.5-3 mg/d dose group versus placebo
Results: The least squares mean difference in MADRS total score change from baseline was statistically significant for cariprazine 1.5-3 mg/d versus placebo in all demographic subgroups analyzed (age: ≤44 years [P2 [P4 [P4 [P < .001], MADRS total score: < 31 [P < .05] or ≥31 [P < .001]).
Conclusions: Pooled cariprazine 1.5-3 mg/d versus placebo was consistently effective in baseline subgroups defined by demographic and clinical characteristics in patients with bipolar depression.
