The Influence of Oxytocin on Automatic Imitation Behaviour in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Research Foundation Flanders
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01767025
First received: January 10, 2013
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

In this study, the influence of oxytocin on automatic imitation behaviour is investigated. Healthy adults will be administered with either oxytocin or a placebo, and will perform an imitation-inhibition task (as a measure of automatic imitation behaviour). To determine the specificity of the oxytocin effect, an unrelated cognitive task (Stroop task) will also be presented.


Condition Intervention Phase
Healthy
Drug: Oxytocin
Drug: Sea water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • To evaluate the automatic imitation behaviour 45 minutes after drug administration [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Since the effects of oxytocin are only visible after 45 minutes, participants will have to wait 45 minutes before starting the experimental tasks. In the meantime, they will be given an unrelated cognitive-emotional filler task which will last ± 30 minutes. Afterwards, they will perform two experimental tasks: an imitation-inhibition task and a cognitive control task (Stroop task).


Enrollment: 60
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin
Oxytocin 24 IU (3 puffs) per nostril
Drug: Oxytocin
Placebo Comparator: Sea water
Sea water 3 puffs per nostril
Drug: Sea water

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • non-smoker

Exclusion Criteria:

  • no pacemaker, deep brain stimulation electrodes or other stimulation devices
  • normal neurological history (no brain operations, migraine, epilepsy, alcoholism
  • no epilepsy in family
  • no chronic disease(s) that require constant medication (asthma, hypertension, diabetes)
  • no medication 24h prior to experiment
  • no alcohol or caffeine 2h prior to experiment
  • no sleep deprivation 24h prior to experiment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767025

Locations
Belgium
Ghent University, Faculty of Psychology and Educational Sciences
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Research Foundation Flanders
Investigators
Principal Investigator: Guy T'Sjoen, MD, PhD Ghent University, Faculty of Endrocrinology
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01767025     History of Changes
Other Study ID Numbers: 2012/550
Study First Received: January 10, 2013
Last Updated: January 16, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Ghent:
Influence
oxytocin
automatic imitation
behaviour
volunteers

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014