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临床试验/NCT03428906
NCT03428906已完成不适用

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

Beijing Normal University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年5月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Functional network organization alterations in brain under resting state fMRI after drug administration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy subjects without past or current psychiatric or neurological disorders

排除标准

  • with MRI Contraindications

研究组 & 干预措施

Oxytocin

Experimental

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) .

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

Placebo contains all ingredients except for the peptide in three puffs of 1.33 IU per 2.24mg nostril.

干预措施: Placebo (Drug)

结局指标

主要结局

Functional network organization alterations in brain under resting state fMRI after drug administration

时间窗: 70~85 minutes 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.

Behavior,brain activities and representation patterns in the emotional judgement task after drug administration

时间窗: 60~75 minutes 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.

Behavior, dynamics brain activities and networks in the model-based decision making task after drug administration

时间窗: 35~60 minutes 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.

Relationship of functional network organization in brain across resting state and task-based fMRI after drug administration

时间窗: 60~85 minutes 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.

次要结局

未报告次要终点

研究者

发起方
Beijing Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ma, yina

Principal Investigator

Beijing Normal University

研究点 (1)

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