INtranasal OXyTocin for the Treatment of Autism Spectrum Disorders (ASD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD
研究概览
简要总结
There is substantial evidence from animal model and healthy control data, that oxytocin is involved in the modulation of social cognition. In addition, recent genetics and plasma level studies suggest a possible role for oxytocin in the pathophysiology of Autism Spectrum Disorders (ASD). As a large number of children with ASD are transitioning into adulthood and will likely require treatment, the lack of data to make meaningful treatment recommendations to facilitate adult living is an urgent issue. This study will examine the effect of intranasal oxytocin (IN-OXT) on social function in adults with ASD. It is hypothesized that IN-OXT will be superior to placebo in improving social function by the end of study treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intranasal Oxytocin
干预措施: Intranasal Oxytocin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of intranasal oxytocin vs. placebo on social function in adults with ASD
时间窗: 12 weeks
This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social).
次要结局
- Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social cognition in adults with ASD(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social function in adults with ASD(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on a continuous measure of social responsiveness in adults with ASD(12 weeks)
- Safety and tolerability of intranasal oxytocin in adults with ASD(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on quality of life(12 weeks)
- Efficacy of intranasal oxytocin vs. placebo on anxiety(12 weeks)