跳至主要内容
临床试验/NCT01712464
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

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年10月18日最近更新:
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
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

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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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