The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fmri BOLD Response During Empathic Accuracy Task
研究概览
简要总结
This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on complex social cognition in adults with autism spectrum disorders.
详细描述
Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and perform an empathic accuracy task, a novel and ecologically valid measure of complex social cognition, in conjunction with functional magnetic resonance imaging (fMRI). The investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and neural correlates of empathic accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the participant and investigator are blind to drug condition.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In good physical health
- •Meet criteria for ASD according to psychiatric interview using the Diagnostic and Statistic Manual, Fourth Edition (DSM-IV)
- •Must be a history of developmental delay
- •Must meet full criteria for ASD on the Autism Diagnostic Interview- Revised (ADI-R) on either the social or communication domains and within two points on other domain (only if parent available for interview)
- •Must meet full criteria for ASD on the Autism Diagnostic Observation Schedule- Generic (ADOS-G) on the social domain. Meeting for ASD on the communication domain and total domain is not necessary
- •Must have a verbal IQ greater than 75, as measured by the Wechsler Adult Intelligence Scale- Fourth Edition (WAIS- III). Intelligence testing performed at other sites or through another protocol at this site within the past year will also be accepted
- •Capability of performing experimental tasks (i.e. can read and understand task instructions, cooperate with procedures)
- •Informed consent and capacity
- •Female participants must remain on birth control for the duration of the study
排除标准
- •Participants with any primary psychiatric diagnosis at screening
- •Participants with a medical history of neurological disease, including, but not limited to, epilepsy/seizure disorder (except simple febrile seizures), movement disorder, tuberous sclerosis, fragile X, and any other known genetic syndromes, or known abnormal MRI/structural lesion of the brain
- •Participants who are pregnant, who gave birth in the last six months, or who are currently breastfeeding
- •Participants with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being
- •Participants with evidence or history of malignancy or any significant hematological endocrine, cardiovascular (including rhythm disorder), respiratory, renal, hepatic, gastrointestinal disease, or other major medical conditions
- •Participants taking psychoactive medication(s) (e.g., stimulants, antidepressants, antipsychotics, antiepileptics, anxiolytics, clondine)
- •Participants who, in the Investigator's opinion, might not be suitable for the study
- •Participants who are involved in another study whose procedures could influence performance in the current study
- •Female participants who do not stay on birth control for the duration of the study
- •Participants who have a known contraindication to the MRI scan: including sever claustrophobia or any kind of metal implant in the body
研究组 & 干预措施
Syntocinon then Placebo
24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
干预措施: Syntocinon (Drug)
Syntocinon then Placebo
24IU intranasal oxytocin, minimum of 3 weeks off, then placebo
干预措施: Placebo (Drug)
Placebo then Syntocinon
Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
干预措施: Syntocinon (Drug)
Placebo then Syntocinon
Placebo, minimum of 3 weeks off, then 24IU intranasal oxytocin or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Fmri BOLD Response During Empathic Accuracy Task
时间窗: 45 minutes after oxytocin/placebo administration
Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant.
Empathic Accuracy Performance
时间窗: 45 minutes after drug/placebo administration
Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
次要结局
未报告次要终点
研究者
Alexander Kolevzon
Professor
Icahn School of Medicine at Mount Sinai