Oxytocin and the Processing of Social Stress-Associated Chemosignals

NCT03265899 | Completed Phase 1

• 1 other identifier: OXT_OLF_2017
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

  30 min after nasal spray administration

• Response time for facial stimuli ratings.

  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).

  30 minutes after nasal spray administration

Secondary Outcomes (3)

• Questionnaire measurement of mood (PANAS).

  15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment

• Saliva oxytocin concentrations

  immediately 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

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oxytocin DRUG

40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Also known as: Syntocinon-Spray, Novartis

Oxytocin

Placebo DRUG

Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds

Also known as: Placebo-Spray, Novartis

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers
• Right-handed

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

MeSH Terms

Interventions

Oxytocin; lactitol

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rene Hurlemann, MSc MD PhD

  Department of Psychiatry, University of Bonn, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 29, 2017
• Study Start: July 1, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: August 29, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share