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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01767025
Other study ID # 2012/550
Secondary ID
Status Completed
Phase Phase 3
First received January 10, 2013
Last updated January 16, 2013
Start date November 2012
Est. completion date December 2012

Study information

Verified date January 2013
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin

Sea water


Locations

Country Name City State
Belgium Ghent University, Faculty of Psychology and Educational Sciences Ghent

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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