Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Functional connectivity during the resting state between brain systems involved in emotional processing.
研究概览
简要总结
The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.
详细描述
In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to either receive intranasal Oxytocin (24IU, n= 30) or intranasal placebo (nasal spray administration without oxytocin, n = 30). Following treatment administration subjects will undergo a resting state functional magnetic resonance imaging (fMRI) assessment (8min) and next watch a long fear-inducing (horror) movie (10min) followed by a resting state fMRI assessment (8min). Effects of treatment on subjective experience will be assessed using 1-9 Likert scales assessing subjective fear, emotional arousal and escape. Ratings will be acquired before the start of the experiment, after the movie and at the end of the experiment. Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without past or current psychiatric or neurological disorders
- •Right-handedness
- •Normal or corrected-normal version
排除标准
- •History of head injury
- •Medical or psychiatric illness
- •Hypertension
- •General cardio-vascular alteration or diseases
- •Allergy against medications
- •Visual or motor impairments
- •Claustrophobia
- •Drug addiction
- •Nicotine dependence
- •FMRI contradictions
研究组 & 干预措施
Placebo group
Drug: intranasal Placebo
干预措施: intranasal Placebo (Drug)
Oxytoxin group
Drug: intranasal Oxytocin(24IU)
干预措施: intranasal Oxytocin(24IU) (Drug)
结局指标
主要结局
Functional connectivity during the resting state between brain systems involved in emotional processing.
时间窗: Change between the time windows 72-80 minutes (before emotion induction) and 90-98 minutes (after emotion induction) following treatment
1.During the 8min resting state before and after the movie clips the intrinsic connectivity of the brain will be assessed. The intrinsic connectivity will be computed as temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. Effects of Oxytocin on the intrinsic architecture of the brain will be examined by comparing the Oxytocin- and Placebo- treated groups.
次要结局
- Functional and dynamic connectivity during the movie clip will be examined during the fear-induction period (10min movie clip).(80 minutes to 90 minutes after treatment)
研究者
Benjamin Becker
Professor
University of Electronic Science and Technology of China