Oxytocin in Individuals With Spectrum Autism Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Eye tracking
研究概览
简要总结
Observe effects of oxytocin on individuals with autism spectrum disorder
详细描述
To observe the effects of oxytocin on individuals with autism spectrum disorder according to gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is a randomized, double-blind, placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of ASD by DSMV
- •CARS> 30
- •age between 3 and 16 years
- •stable (3 months with medication maintained or without medication)
排除标准
- •pregnant women, infants and
- •participation in another research project of pharmacological or behavioral intervention in progress
- •Use of pituitary hormones, cortisol, androgens and estrogens.
- •heart problems: recent AMI, heart failure.
- •respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.
研究组 & 干预措施
oxytocin spray
oxytocin nose spray dose 0,4IU/kg, once unique dose
干预措施: Oxytocin (Drug)
placebo
saline nose spray, 0,9 %, once unique dose
干预措施: placebo (Other)
结局指标
主要结局
Eye tracking
时间窗: on average of 1 year
Eye tracking program
次要结局
- Nepsy(on average of 1 year)
研究者
Helena Paula Brentani
Prof. DRa
University of Sao Paulo General Hospital