Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence
Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence
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DOI：
10.1176/appi.ajp.159.8.1337
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发表时间：
2002-08-01
影响因子：
17.7
通讯作者：
Findling, RL
中科院分区：
文献类型：
--
作者：
Aman, MG;De Smedt, G;Findling, RL
目的：研究利培酮治疗破坏性行为的近期疗效和安全性。方法：采用多中心、双盲、平行分组研究方法，对118名5~12岁严重破坏性行为和智力低于平均水平(智商36~84，含36~84)的儿童进行研究，每天服用0.02~0.06 mg/kg利培酮口服液或安慰剂。先验的主要疗效测量是尼松格儿童行为评定表的行为问题子量表从基线到终点的得分变化。结果：从第一周到终点，利培酮组在尼松格儿童行为评定表的行为问题子量表上的得分变化显著高于安慰剂组(分别为-15.2和-6.2)。利培酮在终点的所有其他尼松格儿童行为评定量表分量表以及易怒、嗜睡/社交退缩和多动的异常行为检查表分量表、行为问题清单攻击性/破坏性行为分量表、最麻烦症状的视觉模拟分量表和临床总体印象改变评分上的改善程度也显著高于安慰剂。利培酮治疗期间最常见的不良反应是头痛和嗜睡。利培酮的锥体外系症状与安慰剂相当。平均增重2.2公斤。利培酮组和安慰剂组分别为0.9 kg和0.9 kg。结论：利培酮治疗智商低于平均水平的儿童严重破坏性行为是有效的，且耐受性良好。
Objective: The short-term efficacy and safety of risperidone in the treatment of disruptive behaviors was examined in a well-characterized cohort of children with subaverage intelligence.Method: In this 6-week, multicenter, double-blind, parallel-group study of 118 children (aged 5-12 years) with severely disruptive behaviors and subaverage intelligence (IQ between 36 and 84, inclusive), the subjects received 0.02-0.06 mg/kg per day of risperidone oral solution or placebo. The a priori primary efficacy measure was the change in score from baseline to endpoint on the conduct problem subscale of the Nisonger Child Behavior Rating Form.Results: The risperidone group showed significantly greater improvement than did the placebo group on the conduct problem subscale of the Nisonger Child Behavior Rating Form from week I through endpoint (change in score of -15.2 and -6.2, respectively). Risperidone was also associated with significantly greater improvement than placebo on all other Nisonger Child Behavior Rating Form subscales at endpoint, as well as on the Aberrant Behavior Checklist subscales for irritability, lethargy/social withdrawal, and hyperactivity; the Behavior Problems Inventory aggressive/destructive behavior subscale; a visual analogue scale of the most troublesome symptom; and the Clinical Global Impression change score. The most common adverse effects reported during risperidone treatment were headache and somnolence. The extrapyramidal symptom profile of risperidone was comparable to that of placebo. Mean weight increases of 2.2 kg. and 0.9 kg occurred in the risperidone and placebo groups, respectively.Conclusions: Risperidone was effective and well tolerated for the treatment of severely disruptive behaviors in children with subaverage IQ.