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CompletedNCT01606462Updated Dec 3, 2014

Oxytocin and Social Cognition

A Phase 1 interventional study of Oxytocin in Healthy Male Volunteers, sponsored by University Hospital, Bonn. Completed at 1 site in Germany. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-03.

Sponsored by University Hospital, Bonn · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Male
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Study 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.

Read the 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.

02

Conditions studied

  • Healthy Male Volunteers

Keywords

  • oxytocin
  • social cognition
  • fMRI
  • oxytocin receptor gene
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In context

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male volunteers

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
153 participants (actual)

Study arms

  • Experimental
    Oxytocin

    one application of 24 IU oxytocin per volunteer

    Drug: Oxytocin

  • Placebo comparator
    Placebo

    sodium chloride solution, intranasal application, 3 puffs per nostril one application per volunteer

    Drug: Oxytocin

Interventions

  • DrugOxytocin

    intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT

    Also known as: Oxytocin: Syntocinon-Spray, Novartis

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What researchers measure

Primary outcomes

  1. 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'.

    Time frame: two years

Secondary outcomes

  1. 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

    Time frame: two years

  2. The oxytocin effect on social behavior e.g. personal space is questioned

    behavioral testing e.g. personal space

    Time frame: two years

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Study locations

1 site
  • Department of Psychiatry, University of Bonn
    Bonn, 53105, Germany
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01606462
Lead sponsor
University Hospital, Bonn
Responsible party
Rene Hurlemann (MSc MD PhD, University Hospital, Bonn) — Principal investigator
First posted
May 25, 2012
Start date
Jun 2011
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Dec 3, 2014

Study contacts

Rene Hurlemann, MSc MD PhD
principal investigator · Department of Psychiatry, University of Bonn, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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