Oxytocin and Emotion Recognition | NCT01216605

Studies
Oxytocin and Emotion Recognition

NCT01216605

Sponsor

University Hospital Freiburg

Status

Completed

Last Update Posted

Oct 7, 2010Estimated

Enrollment

56Actual

Phase

Phase 4

Conditions

Health

Interventions

Syntocinon 24 IU
Placebo

Countries

Germany

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

ID	Type	Description	Link
DO1312/1-1	Other Grant/Funding Number	German Research Foundation (DFG)

Status Module

Record Verification Date

Oct 2010

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 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

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

Oct 6, 2010

Last Update Posted Date

Oct 7, 2010Estimated

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

The present study was designed to investigate the effects of a single dose of synthetic oxytocin on facial emotion recognition in healthy adult man. Pictures of emotional faces are presented very briefly for a few milliseconds in a backward-masking paradigm in order to vary the level of awareness. In a randomized placebo-controlled between-subject design, recognition performance is compared between a drug (24 IU oxytocin) and a placebo condition. We hypothesize that oxytocin enhances emotion recognition even for facial stimuli processed with limited awareness.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Label	Type	Description	Intervention Names
Oxytocin	Active Comparator		Drug: Syntocinon 24 IU
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Syntocinon 24 IU	Drug		Oxytocin
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance on a facial emotion recognition task		45 min. following drug administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males
18 to 40 years of age

Exclusion Criteria:

Any psychiatric diagnosis life-time
Somatic disease
IQ < 85
Smoker
Psychoactive medication

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
Gregor Domes, PhD	University of Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of PSychiatry University of Rostock		Rostock	D	18055	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided