A Cross Over Randomized Controlled Trial of the Effect of Nasal Ocytocine on Cerebral Activations in Relation With Attachement in the General Population
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- BOLD signal intensity
研究概览
简要总结
The study aims to characterize the cerebral activation modifications related to nasal oxytocin administration during vizualisation of distress images in population of healthy people with different attachement styles.
详细描述
Healthy adult male will be recruited. Their attachement style will be assessed through the Attachement scale interview (ASI).
They will have 2 fMRI sessions, during which emotional images will be presented.
One session will be preceded by a nasal administration of oxytocin and the other session will be preceded by a placebo nasal administration. The order of both administrations will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •comprehension of french
- •having signed the informed consent
排除标准
- •chronic disease (liver failure, kidney failure) and cardiovascular disease
- •hypertensive treatment
- •treatment wich increases QT
- •current hospitalisation
- •fMRI contraindication
- •legal protection
研究组 & 干预措施
avoidant
healthy adult male with avoidant attachement
干预措施: Attachement scale interview (ASI) (Behavioral)
secure
healthy adult male with secure attachement
干预措施: nasal oxytocin or placebo (Drug)
secure
healthy adult male with secure attachement
干预措施: fMRI (Device)
secure
healthy adult male with secure attachement
干预措施: Attachement scale interview (ASI) (Behavioral)
secure
healthy adult male with secure attachement
干预措施: psychometric scales (Behavioral)
avoidant
healthy adult male with avoidant attachement
干预措施: nasal oxytocin or placebo (Drug)
avoidant
healthy adult male with avoidant attachement
干预措施: fMRI (Device)
avoidant
healthy adult male with avoidant attachement
干预措施: psychometric scales (Behavioral)
enmeshed/fearfull
healthy adult male with enmeshed/fearfull attachement
干预措施: nasal oxytocin or placebo (Drug)
enmeshed/fearfull
healthy adult male with enmeshed/fearfull attachement
干预措施: fMRI (Device)
enmeshed/fearfull
healthy adult male with enmeshed/fearfull attachement
干预措施: Attachement scale interview (ASI) (Behavioral)
enmeshed/fearfull
healthy adult male with enmeshed/fearfull attachement
干预措施: psychometric scales (Behavioral)
dual style
healthy adult male with dual attachement style
干预措施: nasal oxytocin or placebo (Drug)
dual style
healthy adult male with dual attachement style
干预措施: fMRI (Device)
dual style
healthy adult male with dual attachement style
干预措施: Attachement scale interview (ASI) (Behavioral)
dual style
healthy adult male with dual attachement style
干预措施: psychometric scales (Behavioral)
结局指标
主要结局
BOLD signal intensity
时间窗: 45 min after intranasal administration of oxytocin or placebo
BOLD signal will be assessed in the brain regions associated with attachement: amygdala, medial prefrontal cortex and dorsolateral prefrontal cortex. Both conditions (placebo vs axytocin) will be compared in the four groups. BOLD signal will be assessed during the visualization of emotional pictures that ellicit distress, comfort or complicity or neural emotion.
次要结局
未报告次要终点