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

October 26, 2018 updated by: Keith Kendrick, University of Electronic Science and Technology of China
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • China, Sichuan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high autistic and oxytocin group
subject with high ASQ scores will receive oxytocin treatment
Behavioral: screen high autistic subjects
screen subjects with high ASQ score
Drug: oxytocin
intranasal administration of oxytocin (24 IU)
Experimental: low autistic and oxytocin group
subject with low ASQ scores will receive oxytocin treatment
Drug: oxytocin
intranasal administration of oxytocin (24 IU)
Behavioral: screen low autistic subjects
screen subjects with low ASQ score
Placebo Comparator: high autistic and placebo group
subject with high ASQ scores will receive placebo treatment
Behavioral: screen high autistic subjects
screen subjects with high ASQ score
Drug: placebo
intranasal administration of placebo (24 IU)
Placebo Comparator: low autistic and placebo group
subject with low ASQ scores will receive placebo treatment
Behavioral: screen low autistic subjects
screen subjects with low ASQ score
Drug: placebo
intranasal administration of placebo (24 IU)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 29, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UESTC-neuSCAN-19

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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