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The Influence of Oxytocin on Pair-bonding and Emotion Regulation

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ClinicalTrials.gov Identifier: NCT02501837
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Syntocinon-Spray Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Influence of Oxytocin on Pair-bonding and Emotion Regulation
Study Start Date : July 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501837


Locations
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Germany
Department of Psychiatry, University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Additional Information:
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Responsible Party: Rene Hurlemann, Antragsteller und verantwortlicher Leiter, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT02501837    
Other Study ID Numbers: OXT_BOND
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by Rene Hurlemann, University Hospital, Bonn:
Healthy women
Additional relevant MeSH terms:
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Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs