- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03293511
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
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
40
Phase
- 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 Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610054
- Recruiting
- School of Life science and Technology, University of Electronic Science and Technology of China
-
Contact:
- Juan Kou, Master
- Email: Joykou.uestc@outlook.com
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Order of administration: oxytocin - placebo
Participants first receive oxytocin (24 IU).
After a washout period of 2 weeks, they receive placebo nasal spray
|
24 IU of oxytocin nasal spray will be applied to each subject.
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).
|
24 IU of oxytocin nasal spray will be applied to each subject.
24 IU of of placebo nasal spray will be applied to each subject.
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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.
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)
June 9, 2017
Primary Completion (Anticipated)
July 1, 2019
Study Completion (Anticipated)
July 1, 2019
Study Registration Dates
First Submitted
September 20, 2017
First Submitted That Met QC Criteria
September 20, 2017
First Posted (Actual)
September 26, 2017
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
- 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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