Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials

JOURNAL OF AFFECTIVE DISORDERS

卷:257

Article

McIntyre, Roger S.^1,2  Masand, Prakash S.³  Earley, Willie⁴  Patel, Mehul⁴ 

[1] Univ Hlth Network, Mood Disorders Psychopharmacol Unit, 399 Bathurst St,MP 9-325, Toronto, ON M5T 2S8, Canada

[2] Brain Cognit Discovery Fdn, Toronto, ON, Canada

[3] Ctr Psychiat Excellence, New York, NY USA

[4] Allergan Plc, Madison, NJ USA

关键词: Bipolar disorder;    Mixed features;    Mixed episodes;    Bipolar mania;    Atypical antipsychotic;    Cariprazine;   

DOI  :  10.1016/j.jad.2019.07.020

来源: Elsevier

【 摘 要 】

Background: When bipolar I disorder (BP-I) mania is accompanied by subsyndromal depressive symptoms, a more complicated illness presentation results. To qualify for the mixed features specifier during mania, the DSM-5 requires >= 3 non-overlapping depressive symptoms (DS); notwithstanding, concerns of this definition's ecological validity and implications for timely diagnosis remain. Methods: Herein, patients were pooled from three similarly-designed pivotal trials of cariprazine compared to placebo for BP-I mania (NCT00488618/NCT01058096/NCT01058668) in post hoc analyses of mixed features using three criteria: >= 3 DS (DSM-5), >= 2 DS, and Montgomery-Asberg Depression Rating Scale (MADRS) total score >= 10. Efficacy of cariprazine compared to placebo was assessed (Week 3) by Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission. Results: In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were >= 3 DS = -3.79 (P = .0248), >= 2 DS = -2.91 (P = .0207), and >= 10 MADRS = -5.49 (P < .0001). More cariprazine- than placebo-treated patients ma YMRS response and remission criteria, reaching significance for response in >= 2 DS (34% versus 47%; number-needed-to-treat [NNT] = 8, P = .0483) and >= 10 MADRS (31% versus 57%, NNT = 4, P < .0001) and for remission in >= 2 DS (27% versus 39%, NNT = 9, P = .0462), >= 10 MADRS (23% versus 44%, NNT = 5, P < .0001). Depressive symptoms were improved compared to placebo, reaching statistical significance in the MADRS >= 10 subgroup (LSMD = -1.59, P = .0082). Limitations: Post hoc analysis, MADRS < 18 entry criterion may have prevented assessment of MADRS changes. Conclusions: Cariprazine significantly reduced manic and depressive symptoms in patients with mixed features with differential efficacy across the subgroups analyzed herein.

【 授权许可】

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