An fMRI Study of the Effect of Intravenous Oxytocin vs. Placebo on Response Inhibition and Face Processing in Autism
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
- 否
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
干预措施: Oxytocin (Drug)
Placebo
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
Evdokia Anagnostou
Adjunct Assistant Professor
Icahn School of Medicine at Mount Sinai
