- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05920707
Common and Differentiated Representations Between Social Exclusion and Social Separation
June 27, 2023 updated by: Weihua Zhao, University of Electronic Science and Technology of China
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
120
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 Contact
- Name: Keith M Kendrick, Dr
- Phone Number: +86-28-61830811
- Email: k.kendrick.uestc@gmail.com
Study Contact Backup
- Name: Weihua Zhao, Dr
- Phone Number: +8618780247797
- Email: zarazhao@uestc.edu.cn
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- University of Electronic Science and Technology of China(UESTC)
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy subjects;
- Without any past or present psychiatric or neurological disorders;
- Without any current psychotherapeutic medication.
EXclusion Criteria:
- With any past or present psychiatric or neurological disorders;
- With any current psychotherapeutic medication.
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: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intranasal Oxytocin
Administer oxytocin (24 IU) intranasally.
|
Administer oxytocin (24 IU) intranasally, 6 individual 0.1 ml puffs (4 IU/0.
1ml), three puffs per nostril one every 30 seconds.
|
Active Comparator: Intranasal Arginine Vasopressin
Administer Arginine Vasopressin (20 IU) intranasally.
|
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.
|
Placebo Comparator: Intranasal placebo
Administer placebo intranasally.
|
Administer placebo intranasally, 6 individual 0.1 ml puffs, three puffs per nostril one every 30 seconds.
|
No Intervention: Intranasal nothing (control)
Control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
45 minutes after treatment administration
|
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
|
Immediately after fMRI scanning
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Siying Wang, Dr, University of Electronic Science and Technology of China
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)
April 20, 2023
Primary Completion (Estimated)
September 20, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
June 16, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 28, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-93
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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