Global improvement with cariprazine in the treatment of bipolar I disorder and schizophrenia: A pooled post hoc analysis

INTRODUCTION: Global rating scale measures are useful for assessing the clinical relevance of patient change. Cariprazine, a dopamine D(3) and D(2) receptor partial agonist, is FDA‐approved for the adult treatment of acute manic/mixed episodes of bipolar I disorder and schizophrenia. Post hoc evaluations of Clinical Global Impressions‐Severity (CGI‐S) scores from the cariprazine pivotal trials in both indications were conducted. METHODS: Data from 3 bipolar mania and 3 schizophrenia trials were pooled by indication (bipolar disorder = 1033; schizophrenia = 1466). Cariprazine‐ and placebo‐treated patients were categorised by baseline CGI‐S scores; the proportion of patients who improved from more severe categories at baseline to less severe categories at end‐point was evaluated using a logistic regression model. Correlations between Young Mania Rating Scale and Positive and Negative Syndrome Scale total score changes and category shifts were also evaluated. RESULTS: In both disease states, more cariprazine‐ than placebo‐treated patients had improved CGI‐S scores at end‐point; more placebo‐treated patients had worse end‐point scores. More cariprazine‐ vs placebo‐treated patients shifted from the extremely/severely ill to mildly ill/better category (bipolar disorder = 55% vs 36%, odds ratio [OR] = 2.1; P = .09; schizophrenia = 42% vs 18%, OR = 3.4, P<.01). ORs was statistically significant in favour of cariprazine in shifts from marked and moderate illness to borderline/normal in both indications (P < .05). Correlations between rating scale improvement and category shift were greatest in patients with extreme/severe baseline illness for bipolar disorder (−0.853) and schizophrenia (−0.677). CONCLUSIONS: Post hoc analyses showed that more cariprazine‐ than placebo‐treated patients with bipolar mania or schizophrenia had statistically significant and clinically meaningful CGI‐S improvement.