HealthyEarly Phase 1NCT02741063
Oxytocin Effect on Attentional Bias Towards Emotional Expression Faces in Individuals With High and Low Autistic Traits: A Functional Magnetic Resonance Imaging (fMRI) Study
A Early Phase 1 study testing screen low autistic subjects, screen high autistic subjects and oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial 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 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?
- screen low autistic subjects, screen high autistic subjects and oxytocin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Sep 2019
- Phase
- Early Phase 1
- 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 past or current psychiatric or neurological disorders
Who cannot join
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Keith Kendrick, Dr. contact
China1 site, 1 recruiting
- Recruiting
China, Sichuan
Chengdu, Sichuan, 611731
Lei Xu, gracetsui.uestc@outlook.com
About this study
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screen low autistic subjectsBehavioural
screen subjects with low ASQ score
screen high autistic subjectsBehavioural
screen subjects with high ASQ score
oxytocinDrug
intranasal administration of oxytocin (24 IU)
placeboDrug
intranasal administration of placebo (24 IU)
| Study group | Role | What they receive |
|---|---|---|
| high autistic and oxytocin group | Experimental | subject with high ASQ scores will receive oxytocin treatment Receives: Behavioral: screen high autistic subjects; Drug: oxytocin |
| low autistic and oxytocin group | Experimental | subject with low ASQ scores will receive oxytocin treatment Receives: Behavioral: screen low autistic subjects; Drug: oxytocin |
| high autistic and placebo group | Placebo comparator | subject with high ASQ scores will receive placebo treatment Receives: Behavioral: screen high autistic subjects; Drug: placebo |
| low autistic and placebo group | Placebo comparator | subject with low ASQ scores will receive placebo treatment Receives: Behavioral: screen low autistic subjects; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
attentional bias toward emotional expression faces
attentional bias was measured by the accuracy of each emotional faces in the RSVP task
Measured: 1 hour
Secondary outcomes (1)
brain activity during RSVP task
brain activity was measured by the fMRI scanner
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- Keith Kendrick, Dr., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741063
- Sponsor's protocol ID
- UESTC-neuSCAN-19
- Status last verified
- Oct 2018
- First submitted
- 30 Mar 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
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 Effect on Attentional Bias Towards Emotional Expression Faces in Individuals With High and Low Autistic Traits: A Functional Magnetic Resonance Imaging (fMRI) Study
- ClinicalTrials.gov ID
- NCT02741063
- Acronym / sponsor ID
- UESTC-neuSCAN-19
- Conditions
- Healthy
- Keywords
- oxytocin, attentional bias, Autism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Apr 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high autistic and oxytocin group | Experimental | Behavioral: screen high autistic subjects, Drug: oxytocinsubject with high ASQ scores will receive oxytocin treatment |
| low autistic and oxytocin group | Experimental | Behavioral: screen low autistic subjects, Drug: oxytocinsubject with low ASQ scores will receive oxytocin treatment |
| high autistic and placebo group | Placebo comparator | Behavioral: screen high autistic subjects, Drug: placebosubject with high ASQ scores will receive placebo treatment |
| low autistic and placebo group | Placebo comparator | Behavioral: screen low autistic subjects, Drug: placebosubject with low ASQ scores will receive placebo treatment |
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 past or current psychiatric or neurological disorders
Key exclusion criteria (3 listed)
- history of head injury;
- claustrophobia;
- medical or psychiatric illness.
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 |
|---|---|---|
| screen low autistic subjectsscreen subjects with low ASQ score | Behavioural | low autistic and oxytocin group, low autistic and placebo group |
| screen high autistic subjectsscreen subjects with high ASQ score | Behavioural | high autistic and oxytocin group, high autistic and placebo group |
| oxytocinintranasal administration of oxytocin (24 IU) | Drug | high autistic and oxytocin group, low autistic and oxytocin group |
| placebointranasal administration of placebo (24 IU) | Drug | high autistic and placebo group, low autistic and placebo group |
Primary outcome
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 secondary outcome
brain activity during RSVP task
Time frame: 1 hour
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.
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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.
Keith Kendrick, Dr. contact
Keith Kendrick, Dr. principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing screen low autistic subjects, screen high autistic subjects and oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site 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 3 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 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kendrick, Dr. (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?
attentional bias toward emotional expression faces (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.