- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05245708
Effects of Oxytocin on Reinforcement Learning and Interoception
January 17, 2024 updated by: Shuxia Yao, University of Electronic Science and Technology of China
The Modulatory Effects of Oxytocin on Reinforcement Learning and Interoceptive Processing
The main aim of the study is to investigate whether intranasal oxytocin has effects on reinforcement learning under dynamic environment and interoceptive processing based on behavioral and electroencephalogram (EEG) responses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
(1) Participants first complete a probabilistic reward learning task 45 minutes after treatment with behavioral (response time and accuracy) and EEG data (ERP components such as FRN, ERN and P300) being collected during this task.
(2) A resting-state recording and a heartbeat counting task are conducted following the learning task with ECG and EEG data being collected.
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), the Cognitive Flexibility Inventory(CFI), 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 tasks.
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
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy subjects without any past or present psychiatric or neurological disorders.
Exclusion Criteria:
- History of brain injury medical or mental illness.
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.
|
Each subject will be assigned to 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.
|
Each subject will be assigned to intranasal placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral index in the learning task: chioce accuracy
Time Frame: 45-65 minutes after treatment administration
|
The accuracy of subjects choosing the better option.
|
45-65 minutes after treatment administration
|
Behavioral index in the heartbeat counting task: interoceptive accuracy
Time Frame: 65-75 minutes after treatment administration
|
Individuals' ability to perceive internal cardiac signals
|
65-75 minutes after treatment administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ERP components in the learning task: ERN, FRN, P300, N2pc
Time Frame: 45-65 minutes after treatment administration
|
ERN and FRN are indices of reward expectancy and prediction error in reinforcement learning.
P300 is associated with attention allocation.
N2pc is an early component associated with visual selective attention.
|
45-65 minutes after treatment administration
|
ERP components in the heartbeat counting task: heartbeat-evoked potential (HEP)
Time Frame: 65-75 minutes after treatment administration
|
HEP is a scalp event-related potential that reflects cortical processing of cardiac interoceptive signals
|
65-75 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)
April 15, 2021
Primary Completion (Actual)
September 20, 2021
Study Completion (Actual)
December 15, 2021
Study Registration Dates
First Submitted
February 7, 2022
First Submitted That Met QC Criteria
February 8, 2022
First Posted (Actual)
February 18, 2022
Study Record Updates
Last Update Posted (Estimated)
January 19, 2024
Last Update Submitted That Met QC Criteria
January 17, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-83
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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