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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subjects without past or current psychiatric or neurological disorders Exclusion Criteria: with MRI Contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety. Subjects receiving an intranasal spray of OXT (8 IU or 13.44 mg; Syntocinon-spray; Novartis, Switzerland) . | Drug: Oxytocin<br>* intranasally administrated<br>|
| Placebo Comparator: Placebo<br>Placebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril. | Drug: Placebo<br>* intranasally administrated<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intranasal oxytocin, functional brain network, multiple tasks, resting state