Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks

Healthy Clinical Trial

Official title:

Effects of Intranasal Oxytocin on Male's Functional Brain Network in Resting-state and Tasks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428906
• Other study ID #: IN-OT functional network
• Status: Completed
• Phase: N/A
• First received: February 4, 2018
• Last updated: February 8, 2018
• Start date: May 24, 2016
• Est. completion date: September 12, 2017

Study information

• Verified date: February 2018
• Source: Beijing Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology of functional brain network in resting-state and multiple tasks in healthy males.

Description:

In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers receive intranasal oxytocin or placebo prior to functional magnetic resonance imaging.Subjects will then go through a decision making task, a emotion judgement task and an eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal oxytocin alter the topology of functional brain network in resting-state and multiple tasks in healthy males. State anxiety and mood are measured before and after experiment as covariates to be controlled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 12, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

• with MRI Contraindications

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Oxytocin
intranasally administrated
• Placebo
intranasally administrated

Locations

Country	Name	City	State
China	School of Brain and Cognitive Sciences, Beijing Nornal University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Normal University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional network organization alterations in brain under resting state fMRI after drug administration	Using seed-based and network level functional connectivity analysis, as well as graph theory analysis , functional network organization in brain under eight minutes resting state will be detected and compared between oxytocin and placebo group.	70~85 minutes after drug administration
Primary	Behavior,brain activities and representation patterns in the emotional judgement task after drug administration	Friend or Foe Task is used to measure the verbal versus nonverbal emotional judgement of subjects. Both the response of subjects and the brain activity are recorded in the task. How oxytocin influences the relationship between subjects' behavior and representation pattern of emotional judgement will be investigated through RSA(representation similarity analysis) of brain pattern.	60~75 minutes after drug administration
Primary	Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration	Two-Stage Decision Making Task is used to measure the model-based and model-free decision making process of subjects. The degree of model-based will be calculated by Computational modelling of Subjects' decision making process, and entering as modulation parameter in the OT effect on dynamic brain seed-based and network-based connectivity pattern.	35~60 minutes after drug administration
Primary	Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration	The functional brain activity in resting state, emotional judgement and decision making task will be compared. Both the functional segregation and integration will be measured using graph theory and network connectivity analysis to discover the OT effect on brain network organization across multiple cognitive states.	60~85 minutes after drug administration