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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03846271
Other study ID # UESTC-neuSCAN-61
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2018
Est. completion date July 31, 2019

Study information

Verified date February 2019
Source University of Electronic Science and Technology of China
Contact Zhuang Qian, MD
Phone 13086663679
Email zq19910362@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of the study is to investigate whether intranasal oxytocin (24IU) influences reward sensitivity and performance monitoring during reinforcement learning.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
intranasal oxytocin
24 IU of oxytocin nasal spray will be applied to each subject.
intranasal placebo
an identical amount of placebo nasal spray will be applied to each subject.

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 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. 45-105 minutes after treatment administration
Primary 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. 45-105 minutes after treatment administration
Secondary 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. 45-105 minutes after treatment administration
Secondary 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. 45-105 minutes after treatment administration
Secondary 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. 45-105 minutes after treatment administration
Secondary 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. 45-105 minutes after treatment administration
Secondary 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. 45-105 minutes after treatment administration
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