Oxytocin and Social Cognition

Healthy Male Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606462
• Other study ID #: OXT-071/10
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: December 2, 2014
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Board, Universtiy of Bonn
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

• Current or past psychiatric disease

• Current or past physical illness

• Psychoactive medication

• Tobacco smokers

• MRI contraindication

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• Oxytocin
intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT

Locations

Country	Name	City	State
Germany	Department of Psychiatry, University of Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neural correlates of emotion perception and subsequent memory effects of aversive and neutral stimuli	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	No
Secondary	the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli	behavioral social testing, fMRI analysis using SPM8, OXTR genotyping	two years	No
Secondary	The oxytocin effect on social behavior e.g. personal space is questioned	behavioral testing e.g. personal space	two years	No

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