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临床试验/NCT02350946
NCT02350946
Unknown
2 期

Effects of Oxytocin on Emotion Recognition and Response Inhibition

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 40 人2015年1月

概览

阶段
2 期
干预措施
Oxytocin
疾病 / 适应症
The Impact of Oxytocin on Social Cognition
发起方
RWTH Aachen University
入组人数
40
试验地点
1
主要终点
BOLD response during emotion recognition in contrast with a corresponding control condition.
最后更新
11年前

概览

简要总结

The purpose of this study is to shed light on the basic neurobiological mechanisms which underlie social information processing in healthy men. More specifically, we intend to examine whether a person's social competence level is related to the patterns of neural activity and his visual search strategies during evaluation of social scenes. Furthermore, it will be assessed whether an oxytocin-driven increase in activity in brain areas relevant to the task will facilitate social information processing and thus enhance task performance. Additionally it will be examined whether oxytocin can facilitate response inhibition in an emotional context.

注册库
clinicaltrials.gov
开始日期
2015年1月
结束日期
2017年1月
最后更新
11年前
研究类型
Interventional
研究设计
Crossover
性别
Male

研究者

责任方
Sponsor

入排标准

入选标准

  • MRI- eligibility
  • Subject's ability to fully grasp the type, scope and individual consequences of the study
  • Willingness to participate in and comply with the study procedures as indicated by signing the dated informed consent form

排除标准

  • Left-handedness
  • Regular intake of medication
  • Hypersensitivity towards oxytocin or a chemically similar substance
  • Current or previous neurological or psychiatric disorder
  • Nose surgery or chronic sinus infection
  • Any somatic disorder that may interfere with the experimental procedures, affect the outcome measures or pose a risk for the participant during performance of the experiment

研究组 & 干预措施

Cross over Oxytocin and Placebo

fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14

干预措施: Oxytocin

Cross over Oxytocin and Placebo

fMRI measurement and blood examinations following 26 IU Oxytocin (Syntocinon) on day 1 and following placebo on day 14

干预措施: Placebo

Cross over Placebo and Oxytocin

fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14

干预措施: Oxytocin

Cross over Placebo and Oxytocin

fMRI measurement and blood examinations following placebo on day 1 and following 26 IU Oxytocin (Syntocinon) on day 14

干预措施: Placebo

结局指标

主要结局

BOLD response during emotion recognition in contrast with a corresponding control condition.

时间窗: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

In the Social Detection Task, subjects' brain activity when viewing social scenes will be compared to corresponding control scenes in which no people are shown. In the GoNoGo Task several emotional conditions will be compared to a neutral control condition.

BOLD response during response inhibition (Emotional Go/ Nogo) in contrast with a corresponding control condition.

时间窗: (Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced])

Brain activation during NoGo trials will be compared to brain activation during Go trials from the same emotional condition.

次要结局

  • Total length of fixations on areas of interest (AOIs) assessed via eye-tracking((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))
  • Percentage of correct responses in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))
  • Serum levels of Oxytocin((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))
  • Serum levels of Cortisol((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))
  • Response time in an emotion recognition paradigm (Social Detection Task) and a response inhibition task (Emotional Go/Nogo).((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))
  • Serum levels of Prolaktin((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))
  • Number of fixations on areas of interest (AOIs) assessed via eye-tracking((Day 1: oxytocin, Day: 14:placebo, or vice versa [counterbalanced]))

研究点 (1)

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