Oxytocin Modulates Eye Gaze Behavior During Social Processing

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

Oxytocin Modulates Eye Gaze Behavior During Social Processing and Associations With Trait Autism

The main aim of the study is to examine whether the effects of intranasal oxytocin on eye-gaze behavior towards social stimuli are modulated via individual differences in trait autism

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this double-blind, within subject, placebo controlled design a total of n = 40 healthy male subjects will receive either 24 IU of oxytocin or placebo (interval between administration > two weeks). 45 minutes after treatment subjects will undergo a total of 7 eye-tracking paradigms examining eye-gaze behavior during social processing: (1) dynamic social-nonsocial visual preference task during which movies of dynamic geometric images (DGI) and dynamic social images (DSI) will be presented; (2) non-biological versus biological motion task; (3) social attention and motivation of sharing enjoyment; (4) preference for emotional faces versus schematic faces (emoticons); (5) shared social attention - shared gaze direction with an actor shifting his attention to different objects; (6) preferred visual scanning of face regions in emotional faces; and, (7) eye gaze in response to empathy eliciting visual stimuli. Autistic and associated traits will be assessed using the Autism Spectrum Quotient (ASQ), Social Responsibilities Scale (SRS) and the Interpersonal Reactivity Index (IRI). Within-subject differences in the effects of oxytocin on social eye gazing behaviour will be related to individual differences in autistic traits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610054
        • Recruiting
        • School of Life science and Technology, University of Electronic Science and Technology of China
        • Contact:
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • University of Electronic Science and Technology of China

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

  • History of brain injury
  • Visual impairments
  • Use of medication
  • Contraindications for oxytocin administration

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Order of administration: oxytocin - placebo
Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo nasal spray
Drug: intranasal oxytocin
24 IU of oxytocin nasal spray will be applied to each subject.
Drug: intranasal placebo
24 IU of of placebo nasal spray will be applied to each subject.
Experimental: Order of administration: placebo - oxytocin
Participants first received placebo nasal spray. After a washout period of 2 weeks, they then receive oxytocin (24 IU).
Drug: intranasal oxytocin
24 IU of oxytocin nasal spray will be applied to each subject.
Drug: intranasal placebo
24 IU of of placebo nasal spray will be applied to each subject.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global eye gaze characteristic: differences between oxytocin and placebo treatment
Time Frame: 45-90 minutes after treatment administration
Global eye-gaze patterns will be compared between the administration of oxytocin and placebo
45-90 minutes after treatment administration
Feature-specific eye gaze characteristics: differences between oxytocin and placebo treatment
Time Frame: 45-90 minutes after treatment administration
Localized feature-specific eye gaze patterns will be compared between oxytocin and placebo treatment
45-90 minutes after treatment administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global eye gaze characteristic - associations with autism traits
Time Frame: 45-90 minutes after treatment administration
Within-subject differences in global eye gaze characteristics between the oxytocin and placebo administration will be examined for associations with individual differences in autism traits
45-90 minutes after treatment administration
Feature-specific eye gaze characteristics - associations with trait autism
Time Frame: 45-90 minutes after treatment administration
Within-subject differences in localized feature-specific eye gaze characteristics between the oxytocin and placebo administration will be examined for associations with individual differences in autism traits
45-90 minutes after treatment administration

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Electronic Science and Technology of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Juan Kou, MSc, University of Electronic Science and Technology of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UESCT_neuSCAN_42

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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