Open AccessGlobal improvement with cariprazine in the treatment of bipolar I disorder and schizophrenia: A pooled post hoc analysis
Author(s) -
Durgam Suresh,
Earley Willie,
Lu Kaifeng,
Németh György,
Laszlovszky István,
Volk Stephen,
Litman Robert E.
Publication year - 2017
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/ijcp.13037
Subject(s) - medicine , bipolar i disorder , bipolar disorder , schizophrenia (object oriented programming) , post hoc analysis , placebo , positive and negative syndrome scale , young mania rating scale , mania , psychiatry , rating scale , odds ratio , psychosis , psychology , mood , developmental psychology , alternative medicine , pathology
Summary 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). OR s 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.