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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital, Bonn
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01701180
First received: October 2, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Healthy
Drug: Oxytocin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • Empathy ratings and their neural correlates [ Time Frame: About one hour after the intranasal administration of oxytocin ] [ Designated as safety issue: No ]
    All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.


Secondary Outcome Measures:
  • Neural correlates of pair-bonding [ Time Frame: About one hour after the intranasal administration of oxytocin ] [ Designated as safety issue: No ]
    All subjects are scanned while they view a picture of their mate and and an unknown female.


Estimated Enrollment: 35
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701180

Contacts
Contact: René Hurlemann, MD PhD M.Sc. +49 (0)228 287 15057 renehurlemann@me.com
Contact: Dirk Scheele, M.Sc. +49 (0)228 287 11151 Dirk.Scheele@ukb.uni-bonn.de

Locations
Germany
Department of Psychiatry, University of Bonn Recruiting
Bonn, North Rhine-Westphalia, Germany, 53105
Contact: René Hurlemann, MD PhD M.Sc.    +49 (0)228 287 15057    renehurlemann@me.com   
Contact: Dirk Scheele, M.Sc.    +49 (0)228 287 11151    Dirk.Scheele@ukb.uni-bonn.de   
Sub-Investigator: Dirk Scheele, M.Sc.         
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: René Hurlemann, MD PhD M.Sc. Department of Psychiatry University of Bonn
  More Information

Additional Information:
No publications provided

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
Study First Received: October 2, 2012
Last Updated: August 27, 2013
Health Authority: Germany: Ethics Board, University of Bonn

Keywords provided by University Hospital, Bonn:
Male Volunteers

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014