Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.
Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.
CNS Spectr. 2020 Aug;25(4):502-510. doi: 10.1017/S1092852919001287. Epub 2019 Oct 2.
Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.
Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (-3.3; p = .0008), but not for 3 mg/day (-1.9; p = .0562).
The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.
同时出现抑郁和躁狂症状的混合表现难以治疗。抗抑郁药虽然常用，但疗效证据薄弱，可能增加情绪不稳定的风险。本汇总事后分析的目的是评估卡利拉嗪治疗伴有或不伴有躁狂症状的双相抑郁的疗效。
从符合 DSM-IV-TR 或 DSM-5 双相 I 障碍标准且目前有重度抑郁发作的 3 项随机、双盲、安慰剂对照研究中确定患者有躁狂症状，基线 Young Mania Rating Scale 总分≥4 分。评估卡利拉嗪 1.5mg/天和 3mg/天剂量组与安慰剂的疗效；分析包括从基线到第 6 周 Montgomery-Åsberg 抑郁评定量表（MADRS）总分的最小二乘均数变化。
在随机接受治疗的 1383 例患者中，808 例（58.4%）有躁狂症状。对于有躁狂症状的患者，从基线到第 6 周，MADRS 总分的平均降低幅度，卡利拉嗪 1.5mg/天和 3mg/天与安慰剂相比均显著更大，与安慰剂相比的最小二乘均数差值（LSMD）分别为-2.5（p=0.0033）和-2.9（p=0.0010）；对于无躁狂症状的患者，1.5mg/天的 LSMD 有统计学意义（-3.3；p=0.0008），而 3mg/天的 LSMD 无统计学意义（-1.9；p=0.0562）。
这项事后分析的结果表明，卡利拉嗪可能是伴有或不伴有躁狂症状的双相 I 型抑郁患者的一种合适治疗选择，高剂量可能对有躁狂症状的患者更有效。
