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J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.
This phase 3 trial evaluated the efficacy, safety, and tolerability of low- and high-dose cariprazine in patients meeting DSM-IV-TR criteria for acute manic or mixed episodes associated with bipolar I disorder.
This multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed/flexible-dose study was conducted from February 2010 to December 2011. Patients were randomly assigned to placebo, cariprazine 3-6 mg/d, or cariprazine 6-12 mg/d for 3 weeks of double-blind treatment. Primary and secondary efficacy parameters were change from baseline to week 3 in Young Mania Rating Scale (YMRS) total score and Clinical Global Impressions-Severity of Illness (CGI-S) score, respectively. Post hoc analysis examined change from baseline to week 3 in YMRS single items.
A total of 497 patients were randomized; 74% completed the study. The least squares mean difference (LSMD) for change from baseline to week 3 in YMRS total score was statistically significant in favor of both cariprazine groups versus placebo (LSMD [95% CI]: 3-6 mg/d, -6.1 [-8.4 to -3.8]; 6-12 mg/d, -5.9 [-8.2, -3.6]; P < .001 [both]). Both cariprazine treatment groups showed statistically significant superiority to placebo on all 11 YMRS single items (all comparisons, P < .05). Change from baseline in CGI-S scores was statistically significantly greater in both cariprazine groups compared with placebo (LSMD [95% CI]: 3-6 mg/d, -0.6 [-0.9 to -0.4]; 6-12 mg/d, -0.6 [-0.9 to -0.3]; P < .001 [both]). The most common (≥ 5% and twice the rate of placebo) treatment-related adverse events for cariprazine were akathisia (both groups) and nausea, constipation, and tremor (6-12 mg/d only).
Results of this study demonstrated that both low- and high-dose cariprazine were more effective than placebo in the treatment of acute manic or mixed episodes associated with bipolar I disorder. Cariprazine was generally well tolerated, although the incidence of akathisia was greater with cariprazine than with placebo.
ClinicalTrials.gov identifier: NCT01058668.
这项 3 期临床试验评估了低剂量和高剂量卡利拉嗪在符合 DSM-IV-TR 双相 I 障碍急性躁狂或混合发作标准的患者中的疗效、安全性和耐受性。
这项多中心、随机、双盲、安慰剂对照、平行分组、固定/灵活剂量研究于 2010 年 2 月至 2011 年 12 月进行。患者被随机分配至安慰剂、卡利拉嗪 3-6mg/d 或卡利拉嗪 6-12mg/d 进行 3 周的双盲治疗。主要和次要疗效参数分别为 Young 躁狂评定量表（YMRS）总分和临床总体印象-严重程度（CGI-S）评分自基线至第 3 周的变化。事后分析考察了 YMRS 单项自基线至第 3 周的变化。
共纳入 497 例患者；74%完成了研究。卡利拉嗪组与安慰剂组相比，YMRS 总分自基线至第 3 周的最小二乘均数差值（LSMD）有统计学意义（LSMD [95%CI]：3-6mg/d，-6.1 [-8.4 至 -3.8]；6-12mg/d，-5.9 [-8.2，-3.6]；P<.001[均]）。卡利拉嗪两组在 YMRS 的所有 11 项单项上均显著优于安慰剂（所有比较，P<.05）。与安慰剂相比，两组卡利拉嗪的 CGI-S 评分自基线的变化均有统计学意义（LSMD [95%CI]：3-6mg/d，-0.6 [-0.9 至 -0.4]；6-12mg/d，-0.6 [-0.9 至 -0.3]；P<.001[均]）。卡利拉嗪最常见（≥5%且是安慰剂的两倍）的治疗相关不良事件为静坐不能（两组）和恶心、便秘和震颤（仅 6-12mg/d）。
这项研究结果表明，低剂量和高剂量卡利拉嗪在治疗双相 I 障碍相关的急性躁狂或混合发作方面均优于安慰剂。卡利拉嗪总体耐受性良好，尽管静坐不能的发生率高于安慰剂。
ClinicalTrials.gov 标识符：NCT01058668。
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