HealthyNCT03293511
Oxytocin Modulates Eye Gaze Behavior During Social Processing
A study testing intranasal oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 2 sites in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- intranasal oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 9 Jun 2017to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without any past or present psychiatric or neurological disorders
Who cannot join
- History of brain injury
- Visual impairments
- Use of medication
- Contraindications for oxytocin administration
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
school of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
Juan Kou, Master, Joykou.uestc@outlook.com
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy
- Being tested
- intranasal oxytocin, intranasal placebo
- Keywords
- Oxytocin, Eye tracking, Autistic trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal oxytocinDrug
24 IU of oxytocin nasal spray will be applied to each subject.
intranasal placeboDrug
24 IU of of placebo nasal spray will be applied to each subject.
| Study group | Role | What they receive |
|---|---|---|
| Order of administration: oxytocin - placebo | Experimental | Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo nasal spray Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
| Order of administration: placebo - oxytocin | Experimental | Participants first received placebo nasal spray. After a washout period of 2 weeks, they then receive oxytocin (24 IU). Receives: Drug: intranasal oxytocin; Drug: intranasal placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global eye gaze characteristic: differences between oxytocin and placebo treatment
Global eye-gaze patterns will be compared between the administration of oxytocin and placebo
Measured: 45-90 minutes after treatment administration
Feature-specific eye gaze characteristics: differences between oxytocin and placebo treatment
Localized feature-specific eye gaze patterns will be compared between oxytocin and placebo treatment
Measured: 45-90 minutes after treatment administration
Secondary outcomes (2)
Global eye gaze characteristic - associations with autism traits
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
Measured: 45-90 minutes after treatment administration
Feature-specific eye gaze characteristics - associations with trait autism
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
Measured: 45-90 minutes after treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start9 Jun 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized placebo-controlled double-blind within-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Juan Kou, MSc, Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293511
- Sponsor's protocol ID
- UESCT_neuSCAN_42
- Status last verified
- Oct 2018
- First submitted
- 20 Sep 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Le J, Kou J, Zhao W, Fu M, Zhang Y, Becker B, Kendrick KM. Oxytocin Facilitation of Emotional Empathy Is Associated With Increased Eye Gaze Toward the Faces of Individuals in Emotional Contexts. Front Neurosci. 2020 Aug 11;14:803. doi: 10.3389/fnins.2020.00803. eCollection 2020.
PubMed 32848571
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Modulates Eye Gaze Behavior During Social Processing and Associations With Trait Autism
- ClinicalTrials.gov ID
- NCT03293511
- Acronym / sponsor ID
- UESCT_neuSCAN_42
- Conditions
- Healthy
- Keywords
- Oxytocin, Eye tracking, Autistic trait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo-controlled double-blind within-subject design
| Arm | Type | Receives |
|---|---|---|
| Order of administration: oxytocin - placebo | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboParticipants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo nasal spray |
| Order of administration: placebo - oxytocin | Experimental | Drug: intranasal oxytocin, Drug: intranasal placeboParticipants first received placebo nasal spray. After a washout period of 2 weeks, they then receive oxytocin (24 IU). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without any past or present psychiatric or neurological disorders
Key exclusion criteria (4 listed)
- History of brain injury
- Visual impairments
- Use of medication
- Contraindications for oxytocin administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intranasal oxytocin24 IU of oxytocin nasal spray will be applied to each subject. | Drug | Order of administration: oxytocin - placebo, Order of administration: placebo - oxytocin |
| intranasal placebo24 IU of of placebo nasal spray will be applied to each subject. | Drug | Order of administration: oxytocin - placebo, Order of administration: placebo - oxytocin |
Primary outcome
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
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
2 secondary outcomes
Global eye gaze characteristic - associations with autism traits
Time frame: 45-90 minutes after treatment administration
Feature-specific eye gaze characteristics - associations with trait autism
Time frame: 45-90 minutes after treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 32848571Le J, Kou J, Zhao W, Fu M, Zhang Y, Becker B, Kendrick KM. Oxytocin Facilitation of Emotional Empathy Is Associated With Increased Eye Gaze Toward the Faces of Individuals in Emotional Contexts. Front Neurosci. 2020 Aug 11;14:803. doi: 10.3389/fnins.2020.00803. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Kou, MSc study chair
University of Electronic Science and Technology of China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intranasal oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith M Kendrick, PhD (86-28-61830811, k.kendrick.uestc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global eye gaze characteristic: differences between oxytocin and placebo treatment (time frame: 45-90 minutes after treatment administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03293511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.