INTRODUCTION: Global rating scale measures are useful for assessing the clinical 
relevance of patient change. Cariprazine, a dopamine D3 and D2 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.