NCT00318162Unknown1 期
Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- play observation
研究概览
简要总结
This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders. The investigators hope to show a positive effect on social functioning and language.
详细描述
Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PDD
排除标准
- 未提供
结局指标
主要结局
play observation
Autism Behavior Checklist (ABC) questionnaire
次要结局
未报告次要终点
研究者
研究点 (1)
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