Oxytocin and Social Cognition

December 2, 2014 updated by: Rene Hurlemann, University Hospital, Bonn

Double-blind, Placebo-controlled, Randomized Study: Oxytocin and OXTR-genotypes Influence Behavioral and Neural Social Reactions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Department of Psychiatry, University of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Oxytocin: Syntocinon-Spray, Novartis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years
The oxytocin effect on social behavior e.g. personal space is questioned
Time Frame: two years
behavioral testing e.g. personal space
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Rene Hurlemann, MSc MD PhD, Department of Psychiatry, University of Bonn, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 23, 2012

First Submitted That Met QC Criteria

May 24, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXT-071/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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