Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts
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
- BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI)
研究概览
简要总结
The main aim of the study is to investigate the modulatory effects of intranasal oxytocin (24IU) on fear in naturalistic social and non-social contexts and the underlying neural mechanisms.
详细描述
In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to receive either intranasal oxytocin (24IU, n= 30) or placebo (n = 30) nasal spray. 45 minutes after treatment the participants will undergo a naturalistic fear induction paradigm during fMRI. During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips. Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear). 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
Oxytoxin group
Drug: intranasal Oxytocin(24IU)
干预措施: intranasal Oxytocin(24IU) (Drug)
Placebo group
Drug: intranasal Placebo
干预措施: intranasal Placebo (Drug)
结局指标
主要结局
BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI)
时间窗: 45 minutes to 70 minutes after treatment
BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI) in response to four conditions of movie clips (Fear-Social\\FS, Fear-Non-social\\FNS, Neutral-Social\\NS, Neutral-Non-social\\NNS). Effects of Oxytocin on the neural basis of fear will be examined by comparing the treatment groups (Oxytocin versus Placebo) with respect to fearful versus non fearful conditions. The investigators expect that Oxytocin will decrease reactivity in emotion reactive brain regions as compared to Placebo.
次要结局
- Experienced fear during the paradigm as assessed by self-reported ratings(45 minutes to 70 minutes after treatment)
研究者
Benjamin Becker
Professor
University of Electronic Science and Technology of China