The Influence of Oxytocin on Pair-bonding and Emotion Regulation

July 15, 2015 updated by: Rene Hurlemann, University Hospital, Bonn
The neuropeptide oxytocin (OXT) has been identified as a key modulator of human social behavior and it has been recently shown that OXT also contributes to pair-bonding in men. However, it is still elusive whether OXT has similar effects in women. In the present study, the investigators examine the effect of intranasal OXT on behavioral ratings of and neural responses to the male partner in female participants. In a second experiment, the modulatory effect of OXT on emotion regulation is investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Department of Psychiatry, University of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy female volunteers
  • In a heterosexual relationship

Exclusion Criteria:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin
24 IU Oxytocin (Syntocinon spray), intranasal application 30 min prior to the experiment
Drug: Syntocinon-Spray
Intranasal administration of 24 IU Oxytocin
Placebo Comparator: Placebo
Intranasal application, containing all ingredients except for the peptide, 3 puffs per nostril
Drug: Syntocinon-Spray
Intranasal administration of 24 IU Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural response to photographs of the partner
Time Frame: About one hour after the intranasal administration of oxytocin
Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the photograph of the partner will be compared with placebo.
About one hour after the intranasal administration of oxytocin
Neural response during the regulation of food craving
Time Frame: About one hour after the intranasal administration of oxytocin
Neural responses will be measured by using functional magnetic resonance imaging (fMRI). In the fMRI analysis the effect of oxytocin on the neural response to the regulation of food craving will be compared with placebo.
About one hour after the intranasal administration of oxytocin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attractiveness ratings of all stimuli
Time Frame: About one hour after the intranasal administration of oxytocin
The effect of oxytocin on attractiveness ratings of the partner will be compared with placebo. Ratings will be obtained by using a visual analog scale.
About one hour after the intranasal administration of oxytocin
Arousal ratings of all stimuli
Time Frame: About one hour after the intranasal administration of oxytocin
The effect of oxytocin on arousal ratings of the partner will be compared with placebo. Ratings will be obtained by using a visual analog scale.
About one hour after the intranasal administration of oxytocin
Food craving ratings
Time Frame: About one hour after the intranasal administration of oxytocin
The effect of oxytocin on food craving ratings will be compared with placebo. Ratings will be obtained by using a visual analog scale.
About one hour after the intranasal administration of oxytocin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXT_BOND

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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