HealthyNCT04413786
Oxytocin's Effects on Face Attentional Processing
A study testing oxytocin treatment in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on attentional processing of emotional faces. 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?
- oxytocin treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2019to 26 Dec 2021
- 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 past or current psychiatric or neurological disorders.
Who cannot join
- history of head injury
- medical or psychiatric illness
Trial locations and contacts
1 site in 1 country.
China1 site
School of life science and technology, University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
Official title: The Modulatory Effect of Oxytocin on Attentional Processing of Emotional Faces
To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on attentional processing of emotional faces.
Read the detailed description
In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate the effect of oxytocin treatment on attentional processing of emotional faces. Subjects complete questionnaires in Chinese versions before treatment administration, including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory, Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search Task. In the first task, subjects need to make a response to judge the position of target after a cue-target is presented. In the second task, subjects are asked to search the target "U" or inverted "U" placed on the nose of emotional/neutral faces and make an choices based on their oorientation. During these phases, subjects' response accuracy, response time and electrophysiological activity (ERP) are recorded.
- Conditions
- Healthy
- Being tested
- oxytocin treatment, placebo treatment
- Keywords
- oxytocin, emotional faces, attention, N2pc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocin treatmentDrug
intranasal administration of oxytocin (24IU)
placebo treatmentDrug
intranasal administration of placebo (24IU)
| Study group | Role | What they receive |
|---|---|---|
| oxytocin group | Experimental | male subjects with oxytocin treatment Receives: Drug: oxytocin treatment |
| placebo group | Placebo comparator | male subjects with placebo treatment Receives: Drug: placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response time in reponse to different emotional face targets.
Response time in discriminating which side (left or right) the emotional face target appear.
Measured: 1 hour
N2pc
N2pc is an enhanced negative event-related potential typically elicited at posterior electrodes (e.g., PO7 and PO8) contralateral to the target presented among distractors between 180 and 300 ms after the onset of stimuli.
display.
Measured: 1 hour
Secondary outcomes (1)
Response accuracy in response to different emotional face targets.
Response accuracy is caculated by the precentage of correct responses among the total responses in discriminating the position (left or right side) of different face conditions.
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 posted4 Jun 2020
- Study start14 Oct 2019
- Primary completion16 Dec 2021
- Study completion26 Dec 2021
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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shuxia Yao, University of Electronic Science and Technology of China
- Investigators
- Shuxia Yao, Doctor, Study director, University of Electronic Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413786
- Sponsor's protocol ID
- UESTC-neuSCAN-71
- Status last verified
- Feb 2022
- First submitted
- 25 May 2020
- Last updated
- 9 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Modulatory Effect of Oxytocin on Attentional Processing of Emotional Faces
- ClinicalTrials.gov ID
- NCT04413786
- Acronym / sponsor ID
- UESTC-neuSCAN-71
- Conditions
- Healthy
- Keywords
- oxytocin, emotional faces, attention, N2pc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 26 Dec 2021 (actual)
- First posted
- 4 Jun 2020 (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.
To investigate whether intranasal oxytocin (24IU) treatment has a regulatory effect on attentional processing of emotional faces.
Detailed description
In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate the effect of oxytocin treatment on attentional processing of emotional faces. Subjects complete questionnaires in Chinese versions before treatment administration, including the Beck Depression Inventory, Autism Spectrum Quotient , Trait Anxiety Inventory, Toronto Alexithymia Scale, Multidimentional Assessment of Interoceptive Awareness. This experiment consists of two tasks including Emotional Face Cue-target Task and Visual Search Task. In the first task, subjects need to make a response to judge the position of target after a cue-target is presented. In the second task, subjects are asked to search the target "U" or inverted "U" placed on the nose of emotional/neutral faces and make an choices based on their oorientation. During these phases, subjects' response accuracy, response time and electrophysiological activity (ERP) are recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin group | Experimental | Drug: oxytocin treatmentmale subjects with oxytocin treatment |
| placebo group | Placebo comparator | Drug: placebo treatmentmale subjects with 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 (2 listed)
- history of head injury
- 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 |
|---|---|---|
| oxytocin treatmentintranasal administration of oxytocin (24IU) | Drug | oxytocin group |
| placebo treatmentintranasal administration of placebo (24IU) | Drug | placebo group |
Primary outcome
Response time in reponse to different emotional face targets.
Time frame: 1 hour
Response time in discriminating which side (left or right) the emotional face target appear.
N2pc
Time frame: 1 hour
N2pc is an enhanced negative event-related potential typically elicited at posterior electrodes (e.g., PO7 and PO8) contralateral to the target presented among distractors between 180 and 300 ms after the onset of stimuli. display.
1 secondary outcome
Response accuracy in response to different emotional face targets.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
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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.
Shuxia Yao, Doctor study director
University of Electronic Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxytocin treatment 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 2 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: finished, as of the sponsor's last update on 9 Feb 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response time in reponse to different emotional face targets. (time frame: 1 hour). 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?
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 9 Feb 2022.