Oxytocin Effect on Attentional Bias Towards Emotional Exp... | NCT02741063

Studies
Oxytocin Effect on Attentional Bias Towards Emotional Expression Faces in Individuals With High and Low Autistic Traits: A Functional Magnetic Resonance Imaging (fMRI) Study

NCT02741063

Sponsor

University of Electronic Science and Technology of China

Status

Unknown status

Last Update Posted

Oct 29, 2018Actual

Enrollment

120Estimated

Phase

Early Phase 1

Conditions

Healthy

Interventions

screen low autistic subjects
screen high autistic subjects
oxytocin
placebo

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

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Mar 30, 2016

First Submission Date that Met QC Criteria

Apr 12, 2016

First Posted Date

Apr 18, 2016Estimated

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 26, 2018

Last Update Posted Date

Oct 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keith Kendrick, Professor, University of Electronic Science and Technology of ChinaPrincipal Investigator

Lead Sponsor

University of Electronic Science and Technology of ChinaOTHER

Collaborators

Not provided

Description Module

Brief Summary

to investigate whether oxytocin alter attentional bias towards emotional expression faces in individuals with high and low autistic traits, and the brain mechanism of this effect

Detailed Description

In the present study, investigator plan to use a double-blind, between-subject placebo controlled design.Firstly, all healthy male subjects' autistic trait levels will be assessed by the Autism Spectrum Quotient (ASQ) and only subjects with higher or lower ASQ score will be recruited in the next experiment and divided into high and low subgroup. Then, subjects are randomly assigned to receive either intranasal administration of oxytocin (24 IU) or placebo. 45 min later, subject need to complete an attentional bias task named rapid serial visual presentation (RSVP) task in fMRI scanner.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high autistic and oxytocin group	Experimental	subject with high ASQ scores will receive oxytocin treatment	Behavioral: screen high autistic subjects Drug: oxytocin
low autistic and oxytocin group	Experimental	subject with low ASQ scores will receive oxytocin treatment	Behavioral: screen low autistic subjects Drug: oxytocin
high autistic and placebo group	Placebo Comparator	subject with high ASQ scores will receive placebo treatment	Behavioral: screen high autistic subjects Drug: placebo
low autistic and placebo group	Placebo Comparator	subject with low ASQ scores will receive placebo treatment	Behavioral: screen low autistic subjects Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
screen low autistic subjects	Behavioral	screen subjects with low ASQ score	low autistic and oxytocin group low autistic and placebo group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
attentional bias toward emotional expression faces	attentional bias was measured by the accuracy of each emotional faces in the RSVP task	1 hour

Secondary Outcomes

Measure	Description	Time Frame
brain activity during RSVP task	brain activity was measured by the fMRI scanner	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

history of head injury;
claustrophobia;
medical or psychiatric illness.

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

Name	Role	Phone	Extension	Email
Keith Kendrick, Dr.	Contact			k.kendrick.uestc@gmail.com

Overall Officials

Name	Affiliation	Role
Keith Kendrick, Dr.	University of Electronic Science and Technology of China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China, Sichuan	Recruiting	Chengdu	Sichuan	611731	China

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins