NCT01712464已完成不适用
Modulation of Reinforcement Learning and Neuronal Activation in Ventral Stratum by Oxytocin - a Pilot Study at Autism Spectrum Disorder
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
- 60
- 试验地点
- 1
- 主要终点
- Bold Signal in nucleus accumbens
研究概览
简要总结
This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 26 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 26 years
- •written informed consent
- •proband understands character, extent and individual consequences of the study
- •competent persons who are able to follow the instructions of the study personnel
- •for ASD patients: assured ASD diagnosis, comply of the ASD criteria ADI-R/ADOS-G
排除标准
- •prosopagnosia
- •anaphylaxis of oxytocin or other chemical substances
- •metal inside the body or other contraindications of mri scan
- •physical illness which can affect the examinations or endanger the proband
- •actual or assumed drug or alcohol abuse
- •persons who are accommodated in an institution because of court or administrative order
- •persons with a relationship of dependence to the sponsor or investigator
- •healthy probands: psychiatric disorder according to ICD-10-WHO F at the moment and in history, continuous drug-intake at time of measurements
- •patients with ASD: psychiatric disorder according to ICD-10-WHO F (except ASD disorder in patient group) during the last 12 month being not treated, continuous drug-intake at time of measurements (psychotropic medication), exception: stimulants used for treatment of attention disorders, if they can come off for the measurements
研究组 & 干预措施
Cross over Oxytocin and Placebo
Other
FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
干预措施: Oxytocin vs. Placebo (Drug)
Cross over Placebo and Oxytocin
Other
FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
干预措施: Oxytocin vs. Placebo (Drug)
结局指标
主要结局
Bold Signal in nucleus accumbens
时间窗: 1 Day
during social learning at one treatment with oxytocin vs placebo
次要结局
- Bold signal in ventral tegmental areal(1 Day)
研究者
研究点 (1)
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