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临床试验/NCT03265899
NCT03265899已完成1 期

Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing

University Hospital, Bonn0 个研究点目标入组 60 人开始时间: 2015年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
60
主要终点
Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).

研究概览

简要总结

The purpose of this study is to determine whether oxytocin modulates the processing of stress-associated chemosignals and which substrates are involved.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers
  • Right-handed

排除标准

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers
  • MRI contraindications (e.g. metal in body, claustrophobia)
  • Medication known to interfere with olfactory processing

研究组 & 干预措施

Oxytocin

Experimental

40 IU Oxytocin, intranasal application 30 min prior to the experiment

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

sodium chloride solution, intranasal application 30 min prior to the experiment

干预措施: Placebo (Drug)

结局指标

主要结局

Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).

时间窗: 30 min after nasal spray administration

After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.

Response time for facial stimuli ratings.

时间窗: 30 min after nasal spray administration

Blood-oxygen-level dependent signal in response to chemosensory cues.

时间窗: 30 minutes after nasal spray administration

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).

次要结局

  • Saliva oxytocin concentrations(immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment)
  • Questionnaire measurement of mood (PANAS).(15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment)
  • Questionnaire measurement of anxiety (STAI).(15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment)

研究者

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rene Hurlemann

Prof. Dr. Dr.

University Hospital, Bonn

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