Oxytocin Effect on Attention Inhibition | NCT03486925

Studies
Oxytocin Effect on Attention Inhibition

NCT03486925

Sponsor

University of Electronic Science and Technology of China

Status

Completed

Last Update Posted

Mar 4, 2019Actual

Enrollment

71Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

oxytocin treatment
placebo treatment

Countries

China

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

Feb 2019

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

Dec 19, 2017Actual

Primary Completion Date

Jul 20, 2018Actual

Completion Date

Aug 28, 2018Actual

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

Mar 27, 2018

First Posted Date

Apr 3, 2018Actual

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

Feb 28, 2019

Last Update Posted Date

Mar 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Benjamin Becker, Professor, University of Electronic Science and Technology of ChinaPrincipal Investigator

Lead Sponsor

University of Electronic Science and Technology of ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Effects of intranasal oxytocin (24IU) on cognitive control of attention

Detailed Description

The cognitive control of attention towards neutral and emotional stimuli represents a key functional domain and disruptions in this domain have been associated with a range of psychiatric disorders. Saccadic eye movement tasks have been used to assess individual differences in the cognitive control of attention and alterations in psychiatric disorders. Recent evidence suggests that the hypothalamic neuropeptide Oxytocin (OXT) may modulate attention allocation and regulation. To this end the present randomized between-subject placebo-controlled experiment examined whether intranasal OXT modulates behavior in an eye-tracking saccade / anti-saccade paradigm in healthy male subjects. The paradigm used non-social (neutral shape) as well as social (happy, sad, angry, fear, and neutral faces) stimuli to explore emotion-specific effects of OXT.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oxytocin group	Experimental		Drug: oxytocin treatment
placebo group	Placebo Comparator		Drug: placebo treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxytocin treatment	Drug	intranasal administration of oxytocin (24IU)	oxytocin group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
emotion-specific saccade latencies	comparison between emotion-specific saccade latencies between the treatment groups (in milliseconds)	45 minutes - 100 minutes after treatment
emotion-specific error rates	comparison between the emotion-specific ratio of unsuccessful anti-saccades between the treatment groups.	45 minutes - 100 minutes after treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male, healthy participants
Non smokers

Exclusion Criteria:

Previous or current medical, psychiatric, neurological disorder
Regular medication
Use of any psychoactive substances in the 24 hours before experiment
Contra-indications for oxytocin
Contra-indications for eye-tracking data acquisition

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Life Science and Technology, University of Electronic Science and Technology of China		Chengdu	Sichuan	611731	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided