Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Home Situations Questionnaire
研究概览
简要总结
This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.
详细描述
PDD can be a profoundly disabling condition across social, emotional, and academic domains. Safe and effective treatments for PDD are needed.
Participants are randomly assigned to receive either risperidone plus parent management training or risperidone alone for 24 weeks. Participants who show deterioration at Week 4 will be offered an alternative mediation treatment, aripiprazole. These participants will remain in their original treatment group (either med alone or med plus parent management training). After 6 months of treatment (Week 24), participants who respond to their treatment will be gradually discontinued from their medication treatment to learn if the response can be sustained without continued medication treatment (This phase of the study was ended in Nov. 2006) Adaptive and behavioral outcomes are assessed during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autistic Disorder, Asperger's Disorder, or Pervasive Developmental Disorder not otherwise specified
- •Weight > 30 lbs
- •IQ >= 35 or mental age of at least 18 months
排除标准
- •Psychotic Disorder
- •History of intolerance or nonresponse to risperidone
- •Pregnancy
- •History of neuroleptic malignant syndrome
研究组 & 干预措施
risperidone plus parent management training
干预措施: Risperidone (Drug)
risperidone plus parent management training
干预措施: Behavior Therapy (Behavioral)
risperidone only
干预措施: Risperidone (Drug)
结局指标
主要结局
Home Situations Questionnaire
时间窗: Week 24
Vineland Daily Living Skills Scale
时间窗: Week 24
次要结局
- Irritability subscale-Aberrant Behavioral Checklist(Week 24)
- Clinical Global Impressions-Improvement (CGI-I)(Week 24)
研究者
Denis Sukhodolsky
Principal Investigator
Yale University
