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临床试验/NCT03041870
NCT03041870已完成不适用

Relationship Between Serotonin and Brain Response to Social Dominance Perception and Emotion: a Combined [11C]DASB-PET/fMRI Study in Humans

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
level of Blood-Oxygen-Level Dependent (BOLD) signal

研究概览

简要总结

Previous studies have already revealed the involvement of the serotoninergic system in the social behavior process. For example, more serotonin (5HT) was found in dominant male adult monkeys. Little is known about the serotoninergic implication in human's social behavior. The project aims to clarify the role of the serotoninergic system in social behavior in relation to the process of social hierarchical information. In order to determine how serotoninergic system is involved, the investigator will use a new technic TEP-fMRI. This technic allows us to measure the brain activity and the serotoninergic transporter occupancy (using the [C11]-DASB) at the same time. The current study aims to investigate whether serotonin transporter (5-HTT) activity correlates with the neural response (BOLD) during the detection of social dominance in facial expressions or other measures of social information processing. Blood sample, SLC6A4 (allele coding for the 5HT transporter) genotyping and neuropsychological questionnaires will give at the investigator more information and allow to investigate whether performance on social information processing is modulated by personality trait and genotype.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • French speaking
  • Normal vision
  • Age from 18 to 45
  • Without psychiatric antecedent
  • Without any neurologic antecedent
  • Not taking psychotropic or anxiolytic drugs
  • Having health insurance coverage

排除标准

  • The subject does not wish to be notified of any anomalies detected during MRI
  • Subjects suffering from claustrophobia
  • Subjects carrying magnetic metal objects that cannot be removed as cochlear implant, surgical clips, piercings, pacemakers, mechanical valves
  • Subjects participating in a clinical trial or being in a period of exclusion from a previous clinical trial
  • Person under guardianship or curatorship or deprived of liberty or in emergencies
  • Taking unauthorized treatment in the month before the completion of the review
  • Person whose physical or mental condition does not allow him to pass the test study

结局指标

主要结局

level of Blood-Oxygen-Level Dependent (BOLD) signal

时间窗: at day 0

The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with \[11C\]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of \[11C\]DASB bonded to the transporter. Our reference region will be the cerebellum.

level of serotonin transporter

时间窗: at day 0

The BOLD signal will be measured using a MRI scanner, and simultaneously we will record the level of serotonin transporter with \[11C\]DASB marker of the serotonin transmission, using a PET signal. We will use the Scatchard method in order to determine the level of \[11C\]DASB bonded to the transporter. Our reference region will be the cerebellum.

次要结局

  • SLC6A4 genotyping(at day 0)
  • Behavioral assessment(at day 0)
  • Testosterone Blood level(after the scan session at day 0)
  • Cortisol Blood level(after the scan session at day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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