Oxytocin and Social Cognition

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01606462
First received: May 23, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine whether oxytocin influences memory of social stimuli and reaction to social stimuli. Furthermore the investigators explore the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli.


Condition Intervention Phase
Healthy Male Volunteers
Drug: Oxytocin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Double-blind, Placebo-controlled, Randomized Study: Oxytocin and OXTR-genotypes Influence Behavioral and Neural Social Reactions

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli [ Time Frame: two years ] [ Designated as safety issue: No ]
    MRI data are analyzed using SPM8 (Wellcome Trust Centre for Neuroimaging, London, UK). In the first level analysis the following conditions are modeled: 'neutral: subsequently remembered', 'neutral: subsequently forgotten', 'aversive: subsequently remembered', and 'aversive: subsequently forgotten'.


Secondary Outcome Measures:
  • the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli [ Time Frame: two years ] [ Designated as safety issue: No ]
    behavioral social testing, fMRI analysis using SPM8, OXTR genotyping

  • The oxytocin effect on social behavior e.g. personal space is questioned [ Time Frame: two years ] [ Designated as safety issue: No ]
    behavioral testing e.g. personal space


Estimated Enrollment: 200
Study Start Date: June 2011
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
one application of 24 IU oxytocin per volunteer
Drug: Oxytocin
intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT
Other Name: Oxytocin: Syntocinon-Spray, Novartis
Placebo Comparator: Placebo
sodium chloride solution, intranasal application, 3 puffs per nostril one application per volunteer
Drug: Oxytocin
intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT
Other Name: Oxytocin: Syntocinon-Spray, Novartis

Detailed Description:

The prevailing view of OXT as a key facilitator of prosocial behaviors has been highly influenced by a plethora of studies in healthy volunteers, which demonstrated increased interpersonal trust, generosity, social learning/empathy and positively biased social stimulus processing as a result of OXT treatment. However, this interpretation is challenged by observations that OXT also promotes envy and schadenfreude (gloating), ethno-centrism (including prejudice, xenophobia, and racial bias), and defensive aggression towards outsiders.We investigate the neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli. Tthe oxytocin effect on personal space is questioned. Additionally the effect of OXTR polymorphism regarding behavioral and neural response is explored.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Current or past psychiatric disease
  • Current or past physical illness
  • Psychoactive medication
  • Tobacco smokers
  • MRI contraindication
  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: NCT01606462

Locations
Germany
Department of Psychiatry, University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Rene Hurlemann, MSc MD PhD Department of Psychiatry, University of Bonn, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Rene Hurlemann, MSc MD PhD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01606462     History of Changes
Other Study ID Numbers: OXT-071/10
Study First Received: May 23, 2012
Last Updated: August 27, 2013
Health Authority: Germany: Ethics Board, Universtiy of Bonn

Keywords provided by University Hospital, Bonn:
oxytocin
social cognition
fMRI
oxytocin receptor gene

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

ClinicalTrials.gov processed this record on October 21, 2014