Mankoski Raymond, Zhao Joan, Carson William H, Mathew Suja J, Forbes Robert A
Bristol-Myers Squibb Co., Plainsboro, New Jersey 08536, USA.
J Child Adolesc Psychopharmacol. 2011 Aug;21(4):359-64. doi: 10.1089/cap.2010.0100. Epub 2011 Aug 8.
The aim of this study was to evaluate the effects of aripiprazole treatment on individual Young Mania Rating Scale (YMRS) line items in pediatric subjects with manic or mixed episodes associated with bipolar I disorder to better understand the discrete symptom improvements.
This was a post hoc analysis of the YMRS line item data from a 4-week, multicenter, randomized, double-blind, placebo-controlled study. Two hundred ninety-six eligible subjects were randomized to aripiprazole 10 mg/day (n = 98), aripiprazole 30 mg/day (n = 99), or placebo (n = 99). The primary endpoint was the mean change in YMRS total scores from baseline to week 4. Effect sizes and treatment effect on individual line items were calculated.
Of the 296 subjects, 237 (80.1%) completed the 4-week study. Seven of the 11 YMRS line items showed a statistically significant improvement in both aripiprazole treatment groups versus placebo. Using the data for the pooled doses, the three YMRS line items with the greatest effect size at week 4 were irritability (effect size = 0.7; treatment effect = 1.43; p < 0.001), aggressive behavior (effect size = 0.7; treatment effect = 1.38; p < 0.001), and increased motor activity/energy (effect size = 0.6; treatment effect = 0.86; p < 0.001).
Aripiprazole improved a broad spectrum of symptoms across the YMRS scale.
本研究旨在评估阿立哌唑治疗对患有与双相I型障碍相关的躁狂或混合发作的儿科患者的个体青年躁狂评定量表（YMRS）单项条目评分的影响，以更好地了解各个症状的改善情况。
这是一项对来自一项为期4周、多中心、随机、双盲、安慰剂对照研究的YMRS单项条目数据的事后分析。296名符合条件的受试者被随机分为阿立哌唑10毫克/天组（n = 98）、阿立哌唑30毫克/天组（n = 99）或安慰剂组（n = 99）。主要终点是从基线到第4周YMRS总分的平均变化。计算了效应量以及对各个单项条目的治疗效果。
在296名受试者中，237名（80.1%）完成了为期4周的研究。11个YMRS单项条目中有7个在阿立哌唑治疗组与安慰剂组相比时显示出统计学上的显著改善。使用合并剂量的数据，在第4周效应量最大的3个YMRS单项条目为易激惹（效应量 = 0.7；治疗效果 = 1.43；p < 0.001）、攻击行为（效应量 = 0.7；治疗效果 = 1.38；p < 0.001）以及运动活动/精力增加（效应量 = 0.6；治疗效果 = 0.86；p < 0.001）。
阿立哌唑改善了YMRS量表上的一系列症状。
