HealthyNCT05920707
Common and Differentiated Representations Between Social Exclusion and Social Separation
A study testing Intranasal Oxytocin and Intranasal Arginine Vasopressin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
Explore the shared or separated neural mechanisms of social exclusion and social segregation and compare differential effects of AVP and OXT on these social interaction function. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Intranasal Oxytocin and Intranasal Arginine Vasopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2023to 1 Oct 2023
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects;
- Without any past or present psychiatric or neurological disorders;
- Without any current psychotherapeutic medication.
Who cannot join
- With any past or present psychiatric or neurological disorders;
- With any current psychotherapeutic medication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China(UESTC)
Chengdu, Sichuan
About this study
Explore the shared or separated neural mechanisms of social exclusion and social segregation and compare differential effects of AVP and OXT on these social interaction function.
Read the detailed description
A large body of research has shown that there are differences in the neural representation between social exclusion and social segregation, but the results are inconsistent, and the exploration of the neural basis is still insufficient. In addition, there are two mainstream theoretical explanations for these differences, namely the construction-level theory and the emotion-based theory, but there is no consistent theoretical model yet. Therefore, further exploration is necessary to confirm the cognitive and neural mechanisms underlying the differences between social exclusion and social segregation, and to attempt to reveal the theoretical explanations for these differences. In this project, the investigators propose to perform behavioral and functional magnetic resonance imaging (fMRI) techniques to examine the shared or separate neural mechanisms of social exclusion and social segregation (exp 1: social exclusion; exp 2: social separation) and investigate the modulatory effects of OXT/AVP on them (PLC/24IU OXT/20IU AVP).
- Conditions
- Healthy
- Being tested
- Intranasal Oxytocin, Intranasal Arginine Vasopressin, Intranasal placebo
- Keywords
- Social exclusion, Social separation, Oxytocin, Arginine Vasopressin, fMRI
- Medical subject headings
- Social Isolation, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal OxytocinDrug
Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0. 1ml), three puffs per nostril one every 30 seconds.
Intranasal Arginine VasopressinDrug
Administer arginine vasopressin (20 IU) intranasally, 6 individual 0.1 ml puffs (3.33 IU/0. 1ml), three puffs per nostril one every 30 seconds.
Intranasal placeboDrug
Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin | Active comparator | Administer oxytocin (24 IU) intranasally. Receives: Drug: Intranasal Oxytocin |
| Intranasal Arginine Vasopressin | Active comparator | Administer Arginine Vasopressin (20 IU) intranasally. Receives: Drug: Intranasal Arginine Vasopressin |
| Intranasal placebo | Placebo comparator | Administer placebo intranasally. Receives: Drug: Intranasal placebo |
| Intranasal nothing (control) | No intervention | Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural index: OXT and AVP effects on fMRI based- social exclusion and social separation tasks
Comparions between OXT and AVP on social exclusion and social separation on brain activity or representations
Measured: 45 minutes after treatment administration
Behavioral index: behavioral ratings of social exclusion and social separation tasks
Comparions between social exclusion and social separation in pain ratings
Measured: Immediately after fMRI scanning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start20 Apr 2023
- Primary completion20 Sep 2023 (estimated)
- Study completion1 Oct 2023 (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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo-controlled double-blind between-subject design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- 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, Weihua Zhao, University of Electronic Science and Technology of China
- Investigators
- Siying Wang, Dr, Study chair, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920707
- Sponsor's protocol ID
- UESTC-neuSCAN-93
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 28 Jun 2023
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common and Differentiated Representations Between Social Exclusion and Social Separation
- ClinicalTrials.gov ID
- NCT05920707
- Acronym / sponsor ID
- UESTC-neuSCAN-93
- Conditions
- Healthy
- Keywords
- Social exclusion, Social separation, Oxytocin, Arginine Vasopressin, fMRI
- 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
- 20 Apr 2023 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 27 Jun 2023 (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.
Explore the shared or separated neural mechanisms of social exclusion and social segregation and compare differential effects of AVP and OXT on these social interaction function.
Detailed description
A large body of research has shown that there are differences in the neural representation between social exclusion and social segregation, but the results are inconsistent, and the exploration of the neural basis is still insufficient. In addition, there are two mainstream theoretical explanations for these differences, namely the construction-level theory and the emotion-based theory, but there is no consistent theoretical model yet. Therefore, further exploration is necessary to confirm the cognitive and neural mechanisms underlying the differences between social exclusion and social segregation, and to attempt to reveal the theoretical explanations for these differences. In this project, the investigators propose to perform behavioral and functional magnetic resonance imaging (fMRI) techniques to examine the shared or separate neural mechanisms of social exclusion and social segregation (exp 1: social exclusion; exp 2: social separation) and investigate the modulatory effects of OXT/AVP on them (PLC/24IU OXT/20IU AVP).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized placebo-controlled double-blind between-subject design
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin | Active comparator | Drug: Intranasal OxytocinAdminister oxytocin (24 IU) intranasally. |
| Intranasal Arginine Vasopressin | Active comparator | Drug: Intranasal Arginine VasopressinAdminister Arginine Vasopressin (20 IU) intranasally. |
| Intranasal placebo | Placebo comparator | Drug: Intranasal placeboAdminister placebo intranasally. |
| Intranasal nothing (control) | No intervention | –Control condition |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects;
- Without any past or present psychiatric or neurological disorders;
- Without any current psychotherapeutic medication.
Key exclusion criteria (2 listed)
- With any past or present psychiatric or neurological disorders;
- With any current psychotherapeutic medication.
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 OxytocinAdminister oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0. 1ml), three puffs per nostril one every 30 seconds. | Drug | Intranasal Oxytocin |
| Intranasal Arginine VasopressinAdminister arginine vasopressin (20 IU) intranasally, 6 individual 0.1 ml puffs (3.33 IU/0. 1ml), three puffs per nostril one every 30 seconds. | Drug | Intranasal Arginine Vasopressin |
| Intranasal placeboAdminister placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds. | Drug | Intranasal placebo |
Primary outcome
Neural index: OXT and AVP effects on fMRI based- social exclusion and social separation tasks
Time frame: 45 minutes after treatment administration
Comparions between OXT and AVP on social exclusion and social separation on brain activity or representations
Behavioral index: behavioral ratings of social exclusion and social separation tasks
Time frame: Immediately after fMRI scanning
Comparions between social exclusion and social separation in pain ratings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Siying Wang, Dr study chair
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 study testing Intranasal Oxytocin and Intranasal Arginine Vasopressin 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 3 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith M Kendrick, Dr (+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?
Neural index: OXT and AVP effects on fMRI based- social exclusion and social separation tasks (time frame: 45 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?
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 28 Jun 2023.