Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin (ODIS)

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

Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin

Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Early 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
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, 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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers
  • In a heterosexual relationship

Exclusion Criteria:

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

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin
24 IU Oxytocin, intranasal application 45 min prior to the experiment
Drug: Oxytocin
24 IU; 3 puffs per nostril, each with 4 IU OXT
Other Names:
  • Oxytocin: Syntocinon-Spray, Novartis
Placebo Comparator: Placebo
Intranasal application, sodium chloride solution, 3 puffs per nostril
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Empathy ratings and their neural correlates
Time Frame: About one hour after the intranasal administration of oxytocin
All subjects are scanned while they view emotional and neutral faces and rate their empathy for these stimuli.
About one hour after the intranasal administration of oxytocin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural correlates of pair-bonding
Time Frame: About one hour after the intranasal administration of oxytocin
All subjects are scanned while they view a picture of their mate and and an unknown female.
About one hour after the intranasal administration of oxytocin

Collaborators and Investigators

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

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: René Hurlemann, MD PhD M.Sc., Department of Psychiatry University of Bonn

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

August 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 4, 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-151/12 (Other Grant/Funding Number: HU1302/2-2 and NEMO)

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.

Clinical Trials on Healthy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe