Effect of cariprazine across the symptoms of mania in bipolar I disorder: Analyses of pooled data from phase II/III trials

Eduard Vieta, Suresh Durgam, Kaifeng Lu, Adam Ruth, Marc Debelle, Stephen Zukin

Research output: Contribution to journalArticlepeer-review

Abstract

Bipolar I disorder is a chronic disorder characterized by episodic recurrences of mania, depression, and mixed affective states interspersed with periods of full or partial remission; subsyndromal residual symptoms between episodes are common and disabling. Cariprazine, an atypical antipsychotic, is a potent dopamine D3 and D2 receptor partial agonist with preferential binding to D3 receptors. Post-hoc analyses of pooled data from 3 positive trials were conducted to evaluate the effect of cariprazine 3-12mg/d on the symptoms of mania in inpatients (18-65 years) with bipolar I disorder and a current manic episode. Analyses were based on the pooled intent-to-treat (ITT) population (placebo=429; cariprazine=608). Mean change from baseline to the end of treatment on individual Young Mania Rating Scale (YMRS) items was analysed using a mixed-effects model for repeated measures (MMRM); categorical symptom severity shifts were analysed using logistic regression. Statistically significant improvement in mean change was seen for cariprazine versus placebo on all 11 YMRS items (p

Original languageEnglish (US)
Pages (from-to)1882-1891
Number of pages10
JournalEuropean Neuropsychopharmacology
Volume25
Issue number11
DOIs
StatePublished - Nov 1 2015
Externally publishedYes

Keywords

  • Atypical antipsychotic
  • Bipolar disorder
  • Bipolar mania
  • Cariprazine
  • Residual symptoms

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health
  • Pharmacology (medical)
  • Biological Psychiatry
  • Neurology
  • Pharmacology

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