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Clinical Trials/NCT05245708
NCT05245708
Completed
Not Applicable

The Modulatory Effects of Oxytocin on Reinforcement Learning and Interoceptive Processing

University of Electronic Science and Technology of China1 site in 1 country80 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Intranasal oxytocin
Conditions
Healthy
Sponsor
University of Electronic Science and Technology of China
Enrollment
80
Locations
1
Primary Endpoint
Behavioral index in the heartbeat counting task: interoceptive accuracy
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
December 15, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Shuxia Yao

Associate Professor

University of Electronic Science and Technology of China

Eligibility Criteria

Inclusion Criteria

  • Healthy subjects without any past or present psychiatric or neurological disorders.

Exclusion Criteria

  • History of brain injury medical or mental illness.

Arms & Interventions

oxytocin

a single dose of 24 international units (IU) of OT will be administered with 3 puffs of treatment to each nostril.

Intervention: Intranasal oxytocin

placebo

a single dose of 24 international units (IU) of placebo will be administered with 3 puffs of treatment to each nostril.

Intervention: intranasal placebo

Outcomes

Primary Outcomes

Behavioral index in the heartbeat counting task: interoceptive accuracy

Time Frame: 65-75 minutes after treatment administration

Individuals' ability to perceive internal cardiac signals

Behavioral index in the learning task: chioce accuracy

Time Frame: 45-65 minutes after treatment administration

The accuracy of subjects choosing the better option.

Secondary Outcomes

  • ERP components in the learning task: ERN, FRN, P300, N2pc(45-65 minutes after treatment administration)
  • ERP components in the heartbeat counting task: heartbeat-evoked potential (HEP)(65-75 minutes after treatment administration)

Study Sites (1)

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