Effects of Oxytocin on Reinforcement Learning
Primary Purpose
Learning Disabilities
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intranasal oxytocin
intranasal placebo
Sponsored by
About this trial
This is an interventional basic science trial for Learning Disabilities focused on measuring Oxytocin, performance monitoring, reinforcement learning
Eligibility Criteria
Inclusion Criteria:
- Age between 18-30
- Male sex
- Right handedness
Exclusion Criteria:
- History of brain injury
- Current or history of psychiatric, neurological or internist disorder
- Current or regular use of medication, psychotropic substances, including nicotine
- Contraindications for Oxytocin
Sites / Locations
- University of Electronic Science and Technology of China(UESTC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oxytocin then placebo
Placebo then oxytocin
Arm Description
Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo.
Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU).
Outcomes
Primary Outcome Measures
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase
Feedback Related Negativity (FRN): a negative ERP component evoked by negative feedback relative to positive feedback during the acquisition phase will be compared between the oxytocin and placebo treatment conditions.
Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase
Error Related Negativity (ERN): a negative ERP component evoked by incorrect responses relative to correct responses during the test phase will be compared between the oxytocin and placebo treatment conditions.
Secondary Outcome Measures
Behavioral index: Response accuracy to superior stimuli during the acquisition phase
Correct responses are defined as choices of the stimulus associated with higher probability positive feedback during the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase
Correct responses are defined as choices of the stimulus associated with highest probability positive feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.
Correct responses are defined as avoidance choices of stimuli associated with highest probability negative feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.
Correct responses are defined as choices of the stimulus associated with higher probability positive feedback. Note that stimuli pairs in this measurement are all associated with positive feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.
Correct responses are defined as avoidance choices of stimuli associated with higher probability negative feedback. Note that stimuli pairs in this measurement are all associated with negative feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Full Information
NCT ID
NCT03846271
First Posted
January 25, 2019
Last Updated
February 17, 2019
Sponsor
University of Electronic Science and Technology of China
1. Study Identification
Unique Protocol Identification Number
NCT03846271
Brief Title
Effects of Oxytocin on Reinforcement Learning
Official Title
The Effects of Intranasal Oxytocin on Reward Sensitivity and Performance Monitoring During Reinforcement Learning: an ERP Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
July 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Electronic Science and Technology of China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.
Detailed Description
A double-blind, within-subject, placebo-controlled pharmacological EEG design will be employed. A total of 35 healthy male subjects will be recruited which will receive either intranasal placebo or oxytocin (24IU) on two separate study days (order counter-balanced, washout period at least 2 weeks). 45 minutes after treatment subjects will undergo a probabilistic feedback reinforcement learning paradigm with concurrent EEG acquisition. During the paradigm subjects will learn the reward probabilities of two different visual stimuli from probabilistic feedback provided by social stimuli (positive, negative emoticon). The paradigm includes an initial acquisition phase and a subsequent test phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Learning Disabilities
Keywords
Oxytocin, performance monitoring, reinforcement learning
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized placebo-controlled double-blind within-subject design
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin then placebo
Arm Type
Experimental
Arm Description
Participants first receive oxytocin (24 IU). After a washout period of 2 weeks, they receive placebo.
Arm Title
Placebo then oxytocin
Arm Type
Experimental
Arm Description
Participants first receive placebo. After a washout period of 2 weeks, they receive oxytocin (24 IU).
Intervention Type
Drug
Intervention Name(s)
intranasal oxytocin
Intervention Description
24 IU of oxytocin nasal spray will be applied to each subject.
Intervention Type
Drug
Intervention Name(s)
intranasal placebo
Intervention Description
an identical amount of placebo nasal spray will be applied to each subject.
Primary Outcome Measure Information:
Title
Neural index: Event-related potential: Feedback Related Negativity (FRN) during acquisition phase
Description
Feedback Related Negativity (FRN): a negative ERP component evoked by negative feedback relative to positive feedback during the acquisition phase will be compared between the oxytocin and placebo treatment conditions.
Time Frame
45-105 minutes after treatment administration
Title
Neural index: Event-related potential: Error Related Negativity (ERN) during the test phase
Description
Error Related Negativity (ERN): a negative ERP component evoked by incorrect responses relative to correct responses during the test phase will be compared between the oxytocin and placebo treatment conditions.
Time Frame
45-105 minutes after treatment administration
Secondary Outcome Measure Information:
Title
Behavioral index: Response accuracy to superior stimuli during the acquisition phase
Description
Correct responses are defined as choices of the stimulus associated with higher probability positive feedback during the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Time Frame
45-105 minutes after treatment administration
Title
Behavioral index: Response accuracy to stimuli associated with highest probability positive feedback during the test phase
Description
Correct responses are defined as choices of the stimulus associated with highest probability positive feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Time Frame
45-105 minutes after treatment administration
Title
Response accuracy avoiding stimuli associated with highest probability negative feedback in the test phase.
Description
Correct responses are defined as avoidance choices of stimuli associated with highest probability negative feedback as learned in the acquisition phase. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Time Frame
45-105 minutes after treatment administration
Title
Response accuracy in response to superior stimuli associated with relative higher probability positive feedback in the test phase.
Description
Correct responses are defined as choices of the stimulus associated with higher probability positive feedback. Note that stimuli pairs in this measurement are all associated with positive feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Time Frame
45-105 minutes after treatment administration
Title
Response accuracy avoiding stimuli associated with higher probability negative feedback in the test phase.
Description
Correct responses are defined as avoidance choices of stimuli associated with higher probability negative feedback. Note that stimuli pairs in this measurement are all associated with negative feedback. Effects of treatment will be analyzed by comparing the performance between the two treatment conditions.
Time Frame
45-105 minutes after treatment administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18-30
Male sex
Right handedness
Exclusion Criteria:
History of brain injury
Current or history of psychiatric, neurological or internist disorder
Current or regular use of medication, psychotropic substances, including nicotine
Contraindications for Oxytocin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuang Qian, MD
Phone
13086663679
Email
zq19910362@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Becker, PhD
Phone
86-28-61830988
Email
ben_becker@gmx.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Kendrick, PhD
Organizational Affiliation
University of Electronic Science and Technology of China(UESTC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Electronic Science and Technology of China(UESTC)
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611731
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effects of Oxytocin on Reinforcement Learning
We'll reach out to this number within 24 hrs