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临床试验/NCT03577457
NCT03577457Unknown不适用

The Interaction Between Oxytocin and Serotonin on the Social-reward Brain Networks and Decision Making

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年2月1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
发起方
入组人数
100
试验地点
1
主要终点
Changes in brain neural activity during the social reward processing as assessed via fMRI

研究概览

简要总结

The primary objective of this study is to identify any interaction between oxytocin and serotonin on neural and behavioral activity related to social reward and decision making by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design

详细描述

Serotonin and oxytocin have been proved to play an important role in social reward processing and decision making in human. The aim of this study is to determine whether they interact in those essential human behaviors by a double-blind, placebo-controlled, between-subject, pharmacological fMRI design, in which 4 groups of healthy males will be administered with a random combination of nasal oxytocin (24 international units, IU) or placebo and acute tryptophan depletion (ATD, 75.2g) or placebo (a tryptophan-balanced mixture, 78.2g). The social-reward related neural activity and behavior will be assessed by a series of social reward task in and out of fMRI scanner and the decision making will be assessed by reversal learning task, ultimatum game (UG) and loss aversion task. The interaction between serotonin and oxytocin on brain networks will also be tested by resting state.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
  • Right-handedness

排除标准

  • History of head injury;
  • Medical or psychiatric illness.
  • High blood pressure, general cardio-vascular alterations
  • History of drug or alcohol abuse or addiction.
  • Allergy against medications or general strong allergies
  • Sleep disorders.
  • Visual or motor impairments

研究组 & 干预措施

male oxytocin and ATD group

Experimental

male subjects receiving oxytocin and ATD treatment

干预措施: ATD treatment (Drug)

male oxytocin and placebo group

Experimental

male subjects receiving oxytocin and ATD-placebo treatment

干预措施: oxytocin nasal spray (Drug)

male oxytocin and ATD group

Experimental

male subjects receiving oxytocin and ATD treatment

干预措施: oxytocin nasal spray (Drug)

male oxytocin and placebo group

Experimental

male subjects receiving oxytocin and ATD-placebo treatment

干预措施: oral placebo treatment (placebo-control for ATD) (Drug)

male placebo and ATD group

Experimental

male subjects receiving oxytocin placebo and ATD treatment

干预措施: ATD treatment (Drug)

male placebo and ATD group

Experimental

male subjects receiving oxytocin placebo and ATD treatment

干预措施: intranasal placebo treatment (placebo-control for oxytocin) (Drug)

male placebo group

Placebo Comparator

male subjects receiving oxytocin placebo and ATD placebo treatment

干预措施: intranasal placebo treatment (placebo-control for oxytocin) (Drug)

male placebo group

Placebo Comparator

male subjects receiving oxytocin placebo and ATD placebo treatment

干预措施: oral placebo treatment (placebo-control for ATD) (Drug)

结局指标

主要结局

Changes in brain neural activity during the social reward processing as assessed via fMRI

时间窗: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo

Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in response to social reward task in different treatment groups.

Changes in the resting state as assessed via fMRI

时间窗: Time Frame: approximately 45 minutes after intranasal administration of oxytocin, or placebo, approximately 5.5h after administration of ATD, or placebo

Resting state activity in the social reward related and decision making brain networks will be compared between the treatment groups

次要结局

  • Behavioral performance in social reward related task(approximately 105 minutes after intranasal administration of oxytocin, or placebo, approximately 6.5h after administration of ATD, or placebo)
  • Associations with Personalities of subjects(before 30mins ATD or placebo administration)
  • Behavioral performance in decision making task(approximately 4h after administration of ATD, or placebo, before nasal spray)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Becker

Professor

University of Electronic Science and Technology of China

研究点 (1)

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