Oxytocin and Social Cognition
Double-blind, Placebo-controlled, Randomized Study: Oxytocin and OXTR-genotypes Influence Behavioral and Neural Social Reactions
1 other identifier
interventional
153
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedDecember 3, 2014
December 1, 2014
2 years
May 23, 2012
December 2, 2014
Conditions
Keywords
Outcome Measures
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'.
two years
Secondary Outcomes (2)
the effect of oxytocin receptor (OXTR) polymorphism in terms of behavioral and neural responses to social stimuli
two years
The oxytocin effect on social behavior e.g. personal space is questioned
two years
Study Arms (2)
Oxytocin
EXPERIMENTALone application of 24 IU oxytocin per volunteer
Placebo
PLACEBO COMPARATORsodium chloride solution, intranasal application, 3 puffs per nostril one application per volunteer
Interventions
intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT
Eligibility Criteria
You may qualify if:
- Healthy male volunteers
You may not qualify if:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, University of Bonn
Bonn, 53105, Germany
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rene Hurlemann, MSc MD PhD
Department of Psychiatry, University of Bonn, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc MD PhD
Study Record Dates
First Submitted
May 23, 2012
First Posted
May 25, 2012
Study Start
June 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 3, 2014
Record last verified: 2014-12