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临床试验/NCT00263796
NCT00263796已完成1 期

An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism

Anagnostou, Evdokia, M.D.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Change in BOLD with oxytocin infusion

研究概览

简要总结

To study the effect of oxytocin on face processing and response inhibition in autistic adults by fMRI.

详细描述

Autism is a developmental disorder affecting approximately 60/10,000 individuals. It is characterized by social and language deficits and repetitive behaviors/restricted interests. Functional imaging is becoming a very useful tool in trying to understand the neurobiology of autism. Oxytocin is a hormone produced by the brain to assist with labor and lactation. Recent evidence suggests that it may be involved in social attachment and in repetitive behaviors. In this project, we will study how oxytocin changes the way the brain of autistic adults processes faces, and deals with response inhibition (the ability to interrupt ongoing responses should they prove ineffective or interfering with attaining a goal). There is currently no functional imaging data assessing the effect of oxytocin on the brain. We will explore the activation patterns in response to oxytocin across circuits involved in social cognition (face fusiform area) and response inhibition (caudate, orbitofrontal and dorsolateral cortex) by administering a specific fMRI task activating those circuits before and during an oxytocin infusion. We will also explore the effect of oxytocin in these areas by administering specific cognitive testing not associated with fMRI before and during oxytocin infusion.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meet DSM-IV, ADI, or ADOS criteria for autism spectrum disorder.
  • Be seen as outpatients
  • Demonstrate capacity to provide authorized informed consent or provide consent for participation by an approved surrogate on the autistic individual's behalf

排除标准

  • Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures.
  • Subjects with epilepsy.
  • Subjects with a history of schizophrenia, schizoaffective disorder or other Axis 1 mental disorders, such as bipolar disorder.
  • Subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile X syndrome, anoxia during birth, neurofibromatosis, hypomelanosis, hypothyroidism, Duchenne muscular dystrophy, and maternal rubella
  • Subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.
  • Subjects with renal or liver disease or abnormalities in blood chemistry.
  • Any metallic prosthesis such as plates, pins and screws, shrapnel, metallic foreign body, vascular or neurosurgical clips that may be incompatible with the MRI and any electrical devices such as a pacemaker or a defibrillator
  • Claustrophobia

研究组 & 干预措施

Pitocin

Experimental

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Change in BOLD with oxytocin infusion

时间窗: baseline and 4 hours

Change in BOLD with oxytocin infusion BOLD - blood-oxygen-level-dependent contrast

次要结局

未报告次要终点

研究者

发起方
Anagnostou, Evdokia, M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Evdokia Anagnostou

Adjunct Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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