A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania
A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania
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DOI：
10.1176/appi.ajp.160.9.1651
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发表时间：
2003-09-01
影响因子：
17.7
通讯作者：
Ingenito, G
中科院分区：
文献类型：
--
作者：
Keck, PE;Marcus, R;Ingenito, G
目的：比较新型抗精神病药阿立哌唑与安慰剂治疗急性躁狂型或混合型双相情感障碍患者的疗效和安全性。方法：这项为期3周的多中心双盲研究随机将262例急性躁狂型或混合型双相情感障碍患者随机分为阿立哌唑30 mg/d(如果耐受性需要可减至15 mg/d)或安慰剂。患者至少在两周内仍在医院接受治疗。主要疗效衡量标准是青年躁狂评定量表总分较基线的平均变化；反应被定义为总分下降大于或等于50%。结果：与安慰剂相比，阿立哌唑在青年躁狂评定量表总分上的平均改善有统计学意义(分别为-8.2和-3.4)，有效率显著高于安慰剂组(40%和19%)。对于关键的疗效变量(根据青年躁狂评定量表的反应；临床总体印象-疾病严重程度的双相版本评分[躁狂]和与前一阶段的变化[躁狂])，阿立哌唑在第4天从安慰剂中分离出来。阿立哌唑的完成率显著高于安慰剂(42%对21%)。在阿立哌唑组和安慰剂组之间，由于不良事件而停药的情况没有显著差异。体重与安慰剂相比无显著变化，阿立哌唑与血清催乳素升高或QTC延长无关。结论：阿立哌唑治疗双相情感障碍急性躁狂或混合性发作的疗效明显优于安慰剂，且在这项随机对照试验中是安全和耐受性良好的。
Objective: The authors compared the efficacy and safety of aripiprazole, a novel antipsychotic, to placebo for treatment of patients in an acute manic or mixed episode of bipolar disorder.Method: This 3-week, multicenter, double-blind study randomly assigned 262 bipolar disorder patients in an acute manic or mixed episode to aripiprazole, 30 mg/day (reduced to 15 mg/day if needed for tolerability), or placebo. Patients remained hospitalized for at least 2 of the weeks. The primary efficacy measure was mean change from baseline in total score on the Young Mania Rating Scale; response was defined as a decrease in score of greater than or equal to50%.Results: Aripiprazole produced statistically significant mean improvements in total score on the Young Mania Rating Scale compared with placebo (-8.2 versus -3.4, respectively) and produced a significantly higher response rate (40% versus 19%). For key efficacy variables (response per Young Mania Rating Scale; Clinical Global Impression-Bipolar Version scores for severity of illness [mania] and change from preceding phase [mania]), aripiprazole separated from placebo by day 4. The completion rate was significantly higher with aripiprazole than with placebo (42% versus 21%). Discontinuations due to adverse events did not differ significantly between the aripiprazole and placebo groups. There were no significant changes in body weight versus placebo, and aripiprazole was not associated with elevated serum prolactin or QTc prolongation.Conclusions: Aripiprazole had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this randomized controlled trial.