The Influence of Oxytocin on Automatic Imitation Behaviou... | NCT01767025

Studies
The Influence of Oxytocin on Automatic Imitation Behaviour in Healthy Adults

NCT01767025

Sponsor

University Ghent

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Healthy

Interventions

Oxytocin
Sea water

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jan 10, 2013

First Submission Date that Met QC Criteria

Jan 10, 2013

First Posted Date

Jan 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Name	Class
Research Foundation Flanders	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug		Oxytocin
Sea water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guy T'Sjoen, MD, PhD	Ghent University, Faculty of Endrocrinology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University, Faculty of Psychology and Educational Sciences		Ghent		9000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D001519	Behavior

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin
D012623	Seawater

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided