Oxytocin and the Processing of Social Stress-Associated Chemosignals
2017年8月25日 更新者：Rene Hurlemann、University Hospital, Bonn
Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing
The purpose of this study is to determine whether oxytocin modulates the processing of stress-associated chemosignals and which substrates are involved.
研究概览
详细说明
Social transmission of stress and fear is not restricted to visual or auditory cues, but extends to the olfactory domain, a phylogenetically more ancient sense.
Exposure to axillary sweat from healthy volunteers undergoing an emotional stressor task evokes a strong vicarious stress response on the behavioral and neural level.Particularly, anxious individuals have been shown to exhibit a heightened sensitivity to social chemosensory stress cues (axillary sweat).
The neuropeptide oxytocin (OXT) exerts anxiolytic and anti-stress effects in visual and auditory modalities, however, it still elusive whether OXT also modulates the processing of stress-associated chemosignals.
Axillary sweat were obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control.Subsequently, subjects completed a forced-choice emotional face recognition task composed of stimuli with varying intensities (neutral to fearful), while they were exposed to both sweat stimuli and a non-social control odor (raspberry) after OXT or placebo administration, respectively.
The investigators expect that OXT selectively diminishes chemosensory-induced behavioral biases and neural responses to stress-related odors.
研究类型
介入性
注册 (实际的)
60
阶段
- 阶段1
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy volunteers
- Right-handed
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindications (e.g. metal in body, claustrophobia)
- Anosmia
- Medication known to interfere with olfactory processing
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Oxytocin
40 IU Oxytocin, intranasal application 30 min prior to the experiment
|
40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
其他名称：
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安慰剂比较：Placebo
sodium chloride solution, intranasal application 30 min prior to the experiment
|
Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).
大体时间：30 min after nasal spray administration
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After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.
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30 min after nasal spray administration
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Response time for facial stimuli ratings.
大体时间：30 min after nasal spray administration
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30 min after nasal spray administration
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Blood-oxygen-level dependent signal in response to chemosensory cues.
大体时间：30 minutes after nasal spray administration
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The modulatory effect of oxytocin on neural correlates Using functional magnetic resonance imaging, signal changes in the amygdala, hippocampus and the anterior cingulate cortex in response to olfactory cues of stress and sport (axillary sweat obtained from an unrelated sample of 30 healthy men undergoing the Trier Social Stress Test and ergometer training as control).
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30 minutes after nasal spray administration
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Questionnaire measurement of mood (PANAS).
大体时间：15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
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15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
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Saliva oxytocin concentrations
大体时间：immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
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immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
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Questionnaire measurement of anxiety (STAI).
大体时间：15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Rene Hurlemann, MSc MD PhD、Department of Psychiatry, University of Bonn, Germany
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年7月1日
初级完成 (实际的)
2016年11月30日
研究完成 (实际的)
2016年11月30日
研究注册日期
首次提交
2017年8月18日
首先提交符合 QC 标准的
2017年8月25日
首次发布 (实际的)
2017年8月29日
研究记录更新
最后更新发布 (实际的)
2017年8月29日
上次提交的符合 QC 标准的更新
2017年8月25日
最后验证
2017年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.