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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05245708
Other study ID # UESTC-neuSCAN-83
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2021
Est. completion date December 15, 2021

Study information

Verified date January 2024
Source University of Electronic Science and Technology of China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 15, 2021
Est. primary completion date September 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria: - Healthy subjects without any past or present psychiatric or neurological disorders. Exclusion Criteria: - History of brain injury medical or mental illness.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Intranasal oxytocin
Each subject will be assigned to intranasal administration of oxytocin (24 IU).
intranasal placebo
Each subject will be assigned to intranasal placebo.

Locations

Country Name City State
China University of Electronic Science and Technology of China (UESTC) Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral index in the learning task: chioce accuracy The accuracy of subjects choosing the better option. 45-65 minutes after treatment administration
Primary Behavioral index in the heartbeat counting task: interoceptive accuracy Individuals' ability to perceive internal cardiac signals 65-75 minutes after treatment administration
Secondary ERP components in the learning task: ERN, FRN, P300, N2pc 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
Secondary ERP components in the heartbeat counting task: heartbeat-evoked potential (HEP) HEP is a scalp event-related potential that reflects cortical processing of cardiac interoceptive signals 65-75 minutes after treatment administration
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