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

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• 作者：Eduard Vieta^a ; ^{evieta@clinic.ub.es" class="auth_mail" title="E-mail the corresponding author} ; Suresh Durgam^b ; Kaifeng Lu^b ; Adam Ruth^c ; Marc Debelle^d ; Stephen Zukin^b
• 关键词：Bipolar disorder ; Bipolar mania ; Atypical antipsychotic ; Cariprazine ; Residual symptoms
• 刊名：European Neuropsychopharmacology
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：25
• 期：11
• 页码：1882-1891
• 全文大小：915 K

文摘

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 3–12 mg/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<0.0001); significantly more cariprazine- versus placebo-treated patients had mild/no symptoms at the end of treatment on 11 YMRS items (p<0.0001) and concurrently on the 4 YMRS core symptoms (irritability, speech, content, and disruptive–aggressive behaviour) (p<0.0001). Significantly more cariprazine- versus placebo-treated patients shifted from a Moderate/Worse or Marked/Worse Symptoms categories to Mild/No Symptoms on all 11 (p<0.0001) and 9 of 11 YMRS items (p<0.05), respectively. Results suggest that cariprazine treatment improved mania across YMRS symptoms; a significant percentage of cariprazine- versus placebo-treated patients had mild/no symptoms at the end of treatment.