NCT01767025

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_3 healthy

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2013

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

January 10, 2013

Last Update Submit

January 16, 2013

Conditions

Healthy

Keywords

Influenceoxytocinautomatic imitationbehaviourvolunteers

Outcome Measures

Primary Outcomes (1)

  • To evaluate the automatic imitation behaviour 45 minutes after drug administration

    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).

    120 minutes

Study Arms (2)

Oxytocin

EXPERIMENTAL

Oxytocin 24 IU (3 puffs) per nostril

Drug: Oxytocin

Sea water

PLACEBO COMPARATOR

Sea water 3 puffs per nostril

Drug: Sea water

Interventions

OxytocinDRUG
Oxytocin
Sea waterDRUG
Sea water

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • non-smoker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University, Faculty of Psychology and Educational Sciences

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Behavior

Interventions

OxytocinSeawater

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsSaline WatersEnvironmentEcological and Environmental PhenomenaBiological Phenomena

Study Officials

  • Guy T'Sjoen, MD, PhD

    Ghent University, Faculty of Endrocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 11, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

BE(1)