Acute Treatment of Pediatric Bipolar I Disorder, Manic or Mixed Episode, With Aripiprazole: A Randomized, Double-Blind, Placebo-Controlled Study
Acute Treatment of Pediatric Bipolar I Disorder, Manic or Mixed Episode, With Aripiprazole: A Randomized, Double-Blind, Placebo-Controlled Study
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DOI：
10.4088/jcp.8125tx9c
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发表时间：
2009-10-01
影响因子：
5.3
通讯作者：
Chang, Kiki
中科院分区：
文献类型：
--
作者：
Findling, Robert L.;Nyilas, Margaretta;Chang, Kiki
目的：为了确定阿立哌唑治疗儿童双相I型障碍，躁狂症或混合发作，或没有psychotic features.Method的有效性和安全性：受试者在2005年3月和2007年2月之间入组阿立哌唑10 mg/d，阿立哌唑30 mg/d，安慰剂的随机，多中心，双盲4周的研究。受试者（n = 296）年龄10 - 17岁，DSM-IV诊断为双相I型精神障碍，目前有躁狂或混合发作，有或无精神病特征，Young躁狂评定量表（YMRS）评分≥ 20。主要疗效变量是YMRS总评分较基线的变化。结果：从第1周开始并持续到第4周，两种剂量的阿立哌唑在YMRS总评分方面均优于安慰剂，均为上级。阿立哌唑10 mg和30 mg在总体改善、躁狂和总体双相情感障碍结局指标方面比安慰剂更有效。阿立哌唑10 mg组、阿立哌唑30 mg组和安慰剂组分别有44.8%、63.6%和26.1%的受试者在第4周达到缓解（YMRS总分降低>= 50%）（两种剂量与安慰剂相比P <0.01）。两种剂量通常耐受良好。最常见的不良事件是锥体外系障碍和嗜睡;阿立哌唑30 mg的发生率高于阿立哌唑10 mg。阿立哌唑10 mg（+0.82 kg）或30 mg（+1.08 kg）组与安慰剂组相比（+0.56公斤）（分别为P=.35和P=.13）。日剂量为10 mg或30 mg的阿立哌唑是一种有效且通常良好的-试验注册：clinicaltrials.gov标识符：NCT 00110461 J Clin Psychiatry 2009;70（10）：1441-1451（C）Copyright 2009 Physicians Postgraduate Press，Inc.
Objectives: To determine the efficacy and safety of aripiprazole for the treatment of pediatric bipolar I disorder, manic or mixed episode, with or without psychotic features.Method: Subjects were enrolled between March 2005 and February 2007 in a randomized, multicenter, double-blind 4-week study of aripiprazole 10 mg/d, aripiprazole 30 mg/d, and placebo. Subjects (n = 296) were 10 to 17 years old with a DSM-IV diagnosis of bipolar I disorder with current manic or mixed episodes, with or without psychotic features, and a Young Mania Rating Scale (YMRS) score >= 20. The primary efficacy variable was change from baseline in the YMRS total score.Results: Both doses of aripiprazole were superior to placebo on the YMRS total score beginning at week I and continuing through week 4. Aripiprazole 10 mg and 30 mg were more effective than placebo on global improvement, mania, and overall bipolar illness outcome measures. Response (>= 50% reduction in YMRS total score) at week 4 was achieved by 44.8%, 63.6%, and 26.1% of subjects in the aripiprazole 10 mg, aripiprazole 30 mg, and placebo groups, respectively (P < .01 both doses vs placebo). Both doses were generally well tolerated. The most common adverse events were extrapyramidal disorder and somnolence; rates were higher for aripiprazole 30 mg compared with aripiprazole 10 mg. Average weight gain was not significantly different between the aripiprazole 10 mg (+0.82 kg) or 30 mg (+1.08 kg) groups compared with the placebo group (+0.56 kg) (P=.35 and P=.13, respectively).Conclusions: Aripiprazole in daily doses of 10 mg or 30 mg is an effective and generally well-tolerated acute treatment for pediatric subjects with bipolar I mania or mixed episodes.Trial Registration: clinicaltrials.gov Identifier: NCT00110461 J Clin Psychiatry 2009;70(10):1441-1451 (C) Copyright 2009 Physicians Postgraduate Press, Inc.