Objective. To investigate the efficacy and safety of risperidone for the treatment of disruptive behavioral symptoms in children with autism and other pervasive developmental disorders (PDD).Methods. In this 8-week, randomized, double-blind, placebo-controlled trial, risperidone/placebo solution (0.01–0.06 mg/kg/day) was administered to 79 children who were aged 5 to 12 years and had PDD. Behavioral symptoms were assessed using the Aberrant Behavior Checklist (ABC), Nisonger Child Behavior Rating Form, and Clinical Global Impression-Change. Safety assessments included vital signs, electrocardiogram, extrapyramidal symptoms, adverse events, and laboratory tests.Results. Subjects who were taking risperidone (mean dosage: 0.04 mg/kg/day; 1.17 mg/day) experienced a significantly greater mean decrease on the irritability subscale of the ABC (primary endpoint) compared with those who were taking placebo. By study endpoint, risperidone-treated subjects exhibited a 64% improvement over baseline in the irritability score almost double that of placebo-treated subjects (31%). Risperidone-treated subjects also exhibited significantly greater decreases on the other 4 subscales of the ABC; on the conduct problem, insecure/anxious, hyperactive, and overly sensitive subscales of the Nisonger Child Behavior Rating Form (parent version); and on the Visual Analog Scale of the most troublesome symptom. More risperidone-treated subjects (87%) showed global improvement in their condition compared with the placebo group (40%). Somnolence, the most frequently reported adverse event, was noted in 72.5% versus 7.7% of subjects (risperidone vs placebo) and seemed manageable with dose/dose-schedule modification. Risperidone-treated subjects experienced statistically significantly greater increases in weight (2.7 vs 1.0 kg), pulse rate, and systolic blood pressure. Extrapyramidal symptoms scores were comparable between groups.Conclusions. Risperidone was well tolerated and efficacious in treating behavioral symptoms associated with PDD in children.
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机译：目的。研究利培酮治疗自闭症和其他普遍性发育障碍（PDD）儿童的破坏性行为症状的疗效和安全性。在这项为期8周的随机，双盲，安慰剂对照试验中，利培酮/安慰剂溶液（0.01–0.06 mg / kg /天）被施用于79名5至12岁并患有PDD的儿童。使用异常行为清单（ABC），Nisonger儿童行为评分表和临床总体印象变化来评估行为症状。安全评估包括生命体征，心电图，锥体束外症状，不良事件和实验室检查。服用利培酮（平均剂量：0.04 mg / kg /天; 1.17 mg /天）的受试者与服用安慰剂的受试者相比，ABC（主要终点）的易怒性次级量表的平均下降显着更大。通过研究终点，利培酮治疗的受试者的易怒性得分较基线水平提高了64％，几乎是安慰剂治疗受试者（31％）的两倍。利培酮治疗的受试者在ABC的其他4个子量表上也表现出明显更大的降低;关于行为问题，尼森格儿童行为评估表（父母版本）的不安全/焦虑，过度活跃和过于敏感的分量表;以及最麻烦症状的视觉模拟量表。与安慰剂组（40％）相比，接受利培酮治疗的受试者（87％）的病情总体改善。嗜睡症是最常报告的不良事件，在72.5％对7.7％的受试者（利培酮与安慰剂）中发现，并且似乎可以通过调整剂量/剂量时间表来控制。经利培酮治疗的受试者的体重（2.7对1.0千克），脉搏率和收缩压的统计学增加明显更大。两组之间的锥体外系症状评分相当。利培酮对儿童PDD相关的行为症状具有很好的耐受性和疗效。
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