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Oxytocin and Social Cognition

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606462
First Posted: May 25, 2012
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn
  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: Triple (Participant, 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 Rene Hurlemann, University Hospital, Bonn:

Primary Outcome Measures:
  • neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli [ Time Frame: two years ]
    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 ]
    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 ]
    behavioral testing e.g. personal space


Enrollment: 153
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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
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): 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:
Responsible Party: Rene Hurlemann, MSc MD PhD, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01606462     History of Changes
Other Study ID Numbers: OXT-071/10
First Submitted: May 23, 2012
First Posted: May 25, 2012
Last Update Posted: December 3, 2014
Last Verified: December 2014

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

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