Effects of Oxytocin Dose Frequency on Behavioral and Neural Responses, and Modulation by Trait Autism and Genotype
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
研究概览
简要总结
The main aim of the study is to examine effects of different dose frequencies of repeated oxytocin administration on neural and behavioral markers of oxytocin in healthy male subjects. In addition modulatory effects of autism traits and oxytocin receptor genotype (OXTR) will be explored.
详细描述
In the present study, healthy male subjects will be screened according to the study inclusion criteria. After enrollment buccal swaps will be collected for genotyping and subjects will be randomly assigned to three experimental groups that will receive treatment for 5 subsequent days: (1) placebo for five days, (2) oxytocin on days 1, 3 and 5, or (3) oxytocin for five days. Behavioral measures, task-based and resting fMRI will be assessed after the first treatment (acute effects) and the last treatment (chronic effects). The task-based fMRI will employ an implicit emotional face processing paradigm and ratings of the facial emotions will be collected after the fMRI.
Moreover, to control for potential confounding effects of relevant traits all participants will complete the following questionnaires: Interpersonal Reactivity Index (IRI),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI). To explore potential modulatory effects of trait autism, all subjects will be administered the Autism Spectrum Quotient (ASQ) scale to assess pre-treatment autism traits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 30 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy adult males
排除标准
- •past or current psychiatric or neurological disorder head trauma substance abuse medication fMRI contraindications (e.g. metal implants)
研究组 & 干预措施
Oxytocin nasal spray(5 doses)
Oxytocin nasal spray for 5 days, 24 IU per day
干预措施: Nasal Sprays (Drug)
Oxytocin nasal spray(3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day.
干预措施: Nasal Sprays (Drug)
Placebo nasal spray(control group)
Placebo nasal spray for 5 days,24 IU per day.
干预措施: Nasal Sprays (Drug)
结局指标
主要结局
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala reactivity towards fearful faces as assessed by fMRI.
时间窗: 45 minutes after treatment (day 1 vs day 5)
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala activity towards fearful faces. Amygdala activity will be assessed using task-based BOLD fMRI analyses.
Between group differences in the changes between acute and chronic administration effects of oxytocin on amygdala resting state connectivity as assessed by fMRI.
时间窗: 45 minutes after treatment (day 1 vs day 5)
Differences between the treatment groups will be determined by examining differential changes of acute treatment (day 1) vs chronic treatment (day 5) on amygdala resting state fMRI connectivity. Amygdala functional connectivity will be examined using a seed to whole brain approach.
次要结局
- Association between trait autism with acute and chronic treatment effects on amygdala activity in response to fearful faces(45 minutes after treatment (day 1 vs day 5))
- Association between trait autism with acute and chronic treatment effects on amygdala resting state connectivity(45 minutes after treatment (day 1 vs day 5))
- Interaction of acute and chronic treatment effects on amygdala activity with oxytocin receptor genotype.(45 minutes after treatment (day 1 vs day 5))
- Interaction of acute and chronic treatment effects on amygdala connectivity with oxytocin receptor genotype.(45 minutes after treatment (day 1 vs day 5))
- Treatment effects on arousal will be assessed by subjects rating their arousal on a 9-point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5(45 minutes after treatment (day 1 vs day 5))
- Treatment effects on intensity will be assessed by subjects rating their intensity on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5(45 minutes after treatment (day 1 vs day 5))
- Treatment effects on valence will be assessed by subjects rating their valence on a 9 point Likert scale in response to the face pictures presented again after their fMRI scans on day 1 and day 5(45 minutes after treatment (day 1 vs day 5))
研究者
Keith Kendrick
professor
University of Electronic Science and Technology of China