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临床试验/NCT00080145
NCT00080145已完成不适用

Risperidone and Behavioral Therapy in Treatment of Children and Adolescents With Autistic Disorder

Yale University3 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2004年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Risperidone (Drug)

risperidone plus parent management training

Active Comparator

干预措施: Behavior Therapy (Behavioral)

risperidone only

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Sukhodolsky

Principal Investigator

Yale University

研究点 (3)

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