A Phase 1 interventional study of Oxytocin and Placebo in Healthy Volunteers, sponsored by University Hospital, Bonn. Completed. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by University Hospital, Bonn · Phase 1, Interventional, and Basic science
The purpose of this study is to determine whether oxytocin modulates the processing of stress-associated chemosignals and which substrates are involved.
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.
Exclusion Criteria:
40 IU Oxytocin, intranasal application 30 min prior to the experiment
Drug: Oxytocin
sodium chloride solution, intranasal application 30 min prior to the experiment
Drug: Placebo
40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
Also known as: Syntocinon-Spray, Novartis
Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
Also known as: Placebo-Spray, Novartis
Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).
After each trial, subjects were asked to use a button response grip to indicate whether they perceived the depicted face as neutral or fearful.
Time frame: 30 min after nasal spray administration
Response time for facial stimuli ratings.
Time frame: 30 min after nasal spray administration
Blood-oxygen-level dependent signal in response to chemosensory cues.
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).
Time frame: 30 minutes after nasal spray administration
Questionnaire measurement of mood (PANAS).
Time frame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Saliva oxytocin concentrations
Time frame: immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Questionnaire measurement of anxiety (STAI).
Time frame: 15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
No study locations are listed for this record.
Plan to share: No
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University Hospital, Bonn