Clinical trial NCT03265899: Oxytocin and the Processing of Social Stress-Associated Chemosignals
Official title: Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Stress-Associated Chemosignals Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced-choice ratings of morphed emotional faces with varying intensities (neutral to fearful).
timeFrame: 30 min after nasal spray administration
measure: Response time for facial stimuli ratings.
timeFrame: 30 min after nasal spray administration
measure: Blood-oxygen-level dependent signal in response to chemosensory cues.
timeFrame: 30 minutes after nasal spray administration
Secondary outcomes:
measure: Questionnaire measurement of mood (PANAS).
timeFrame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
measure: Saliva oxytocin concentrations
timeFrame: immediately before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
measure: Questionnaire measurement of anxiety (STAI).
timeFrame: 15 minutes after nasal spray administration and (on average) 10 minutes after the fMRI experiment
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry, University of Bonn, Germany
name: Rene Hurlemann, MSc MD PhD
role: PRINCIPAL_INVESTIGATOR
References: