- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06405737
Oxytocin's Effect on the Advantageous- and Disadvantageous-inequity
August 12, 2024 updated by: Shuxia Yao, University of Electronic Science and Technology of China
Oxytocin Modulates the Processing of the Advantageous- and Disadvantageous-inequity
The main aim of the study is to investigate whether intranasal oxytocin modulates advantageous- and disadvantageous-inequity and whether oxytocin has similar effects on them or not.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The main aim of the study is to investigate whether intranasal oxytocin modulates advantageous- and disadvantageous-inequity and its underlying neural mechanisms and whether oxytocin has similar effects on them or not.
A double-blinded, placebo-controled, between-subject design is employed in this study.
In a randomized order, a total of 80 healthy males are instructed to self-administrated intranasal spray of oxytocin or placebo.
A modified inequity decision-making task starts 45 minutes after treatment with behavioral (fairness rating, preference rating and the choice rate of unequal option) and fMRI data being collected during this task.
Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS).
Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before and after the task.
Study Type
Interventional
Enrollment (Actual)
80
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 Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- 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 past or current psychiatric or neurological disorders
Exclusion Criteria:
- history of head injury
- pregnant,menstruating,taking oral contraceptives
- medical or psychiatric illness.
- excessive head movement (> 3mm) during scanning
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: oxytocin
a single dose of 24 international units (IU) of OT will be administered with 3 puffs of treatment to each nostril.
|
Subject assigned to receive intranasal administration of oxytocin (24 IU).
|
|
Experimental: placebo
a single dose of 24 international units (IU) of placebo will be administered with 3 puffs of treatment to each nostril.
|
Subjects assigned to receive intranasal administration of placebo (24 IU).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neural indices: fMRI-based measures of the outcome presentation stage
Time Frame: 45-75 minutes after treatment administration
|
Functional magnetic resonance imaging (fMRI) is employed to assess participants' blood-oxygen-level dependent signals when they are confronted with monetary allocations (advantageous-inequity, disadvantageous-inequity, and fair).
|
45-75 minutes after treatment administration
|
|
Behavioral index: fairness rating scores
Time Frame: 45-75 minutes after treatment administration
|
Participants are instructed to rate their perceived levels of fairness to the allocation using a 9-point Likert scale within 4 seconds (1 = very unfair, 9 = very fair).
|
45-75 minutes after treatment administration
|
|
Behavioral index: preference rating scores
Time Frame: 45-75 minutes after treatment administration
|
Participants are instructed to rate their perceived levels of preference to the allocation using a 9-point Likert scale within 4 seconds (1 = not at all, 9 = very preferable).
|
45-75 minutes after treatment administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral index: choice rate of unequal option
Time Frame: 45-75 minutes after treatment administration
|
Participants are instructed to make a hypothetical choice between the actual allocation in the current trial and the other fair option if they were given another chance to re-choose.
|
45-75 minutes after treatment administration
|
|
Neural indices: fMRI-based measures of outcome and re-decision stages
Time Frame: 45-75 minutes after treatment administration
|
Functional magnetic resonance imaging (fMRI) is employed to assess participants' blood-oxygen-level dependent signals when they are instructed to make a hypothetical choice between the actual allocation in the current trial and the other fair option if they were given another chance to re-choose.
|
45-75 minutes after treatment administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yao Shuxia, 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)
January 7, 2024
Primary Completion (Actual)
June 12, 2024
Study Completion (Actual)
June 20, 2024
Study Registration Dates
First Submitted
May 5, 2024
First Submitted That Met QC Criteria
May 5, 2024
First Posted (Actual)
May 8, 2024
Study Record Updates
Last Update Posted (Actual)
August 14, 2024
Last Update Submitted That Met QC Criteria
August 12, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-88
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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