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Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin (ODIS)

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ClinicalTrials.gov Identifier: NCT01701180
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

Brief Summary:
Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.

Condition or disease Intervention/treatment Phase
Healthy Drug: Oxytocin Drug: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin
Study Start Date : August 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Oxytocin
24 IU Oxytocin, intranasal application 45 min prior to the experiment
Drug: Oxytocin
24 IU; 3 puffs per nostril, each with 4 IU OXT
Other Name: Oxytocin: Syntocinon-Spray, Novartis
Placebo Comparator: Placebo
Intranasal application, sodium chloride solution, 3 puffs per nostril
Drug: Placebo



Primary Outcome Measures :
  1. Empathy ratings and their neural correlates [ Time Frame: About one hour after the intranasal administration of oxytocin ]
    All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.


Secondary Outcome Measures :
  1. Neural correlates of pair-bonding [ Time Frame: About one hour after the intranasal administration of oxytocin ]
    All subjects are scanned while they view a picture of their mate and and an unknown female.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers
  • In a heterosexual relationship

Exclusion Criteria:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers

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): NCT01701180


Locations
Germany
Department of Psychiatry, University of Bonn
Bonn, North Rhine-Westphalia, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: René Hurlemann, MD PhD M.Sc. Department of Psychiatry University of Bonn

Additional Information:
Responsible Party: Rene Hurlemann, MSc MD PhD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01701180     History of Changes
Other Study ID Numbers: OXT-151/12
OXT-151/12 ( Other Grant/Funding Number: HU1302/2-2 and NEMO )
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Rene Hurlemann, University Hospital, Bonn:
Male Volunteers

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs