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临床试验/NCT03549182
NCT03549182Unknown不适用

The Influence of Acute Tryptophan Depletion on Emotion and Interference Processing and Potential Moderation by 5HT Genetics (TPH2)

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年3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
50
试验地点
1
主要终点
Neural processing during emotion processing as assessed via fMRI

研究概览

简要总结

The study aims to explore whether acute tryptophan depletion can affect the emotion and interference processing whether this effect is moderated by the TPH2 genotype

详细描述

Based on previous studies suggesting that serotonin, a neurotransmitter, is associated with social & emotional behavior, including emotional reactivity and emotion regulation, the present study aims to explore effects of acute tryptophan depletion (ATD) on emotion processing and emotional interference processing within a randomized double-blind, with-subject, placebo-controlled pharmaco-fMRI experiment. To further examine the potential moderating effects of the genetic makeup of the serotonin system the present study will include a pharmacogenetics imaging approach. Given that TPH2 is the key regulator of the serotonergic signaling pathway, we therefore assessed whether such the effects of tryptophan depletion vary according to the TPH2 genotype. To this end, healthy male TPH2-GG or TPH2-TT carriers will be recruited and will receive ATD (100g) and placebo (102.3g) in a within subject design. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.

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 TPH2-GG carriers with ATD then placebo group

Experimental

male TPH2-GG carriers will first receive ATD, then will receive placebo at least 5 weeks later.

干预措施: ATD treatment (Drug)

male TPH2-GG carriers with ATD then placebo group

Experimental

male TPH2-GG carriers will first receive ATD, then will receive placebo at least 5 weeks later.

干预措施: placebo treatment (Drug)

male TPH2-GG carriers with placebo then ATD group

Experimental

male TPH2-GG carriers will first receive placebo, then will receive ATD at least 5 weeks later.

干预措施: ATD treatment (Drug)

male TPH2-TTcarriers with ATD then placebo group

Experimental

male TPH2-TT carriers will first receive ATD, then will receive placebo at least 5 weeks later.

干预措施: placebo treatment (Drug)

male TPH2-GG carriers with placebo then ATD group

Experimental

male TPH2-GG carriers will first receive placebo, then will receive ATD at least 5 weeks later.

干预措施: placebo treatment (Drug)

male TPH2-TTcarriers with ATD then placebo group

Experimental

male TPH2-TT carriers will first receive ATD, then will receive placebo at least 5 weeks later.

干预措施: ATD treatment (Drug)

male TPH2-TTcarriers with placebo then ATD group

Experimental

male TPH2-TT carriers will first receive placebo,then will receive ATD at least 5 weeks later.

干预措施: ATD treatment (Drug)

male TPH2-TTcarriers with placebo then ATD group

Experimental

male TPH2-TT carriers will first receive placebo,then will receive ATD at least 5 weeks later.

干预措施: placebo treatment (Drug)

结局指标

主要结局

Neural processing during emotion processing as assessed via fMRI

时间窗: 5-6h after administration of ATD, or placebo

Subjects will undergo a validated emotional face paradigm. To assess genotype x ATD interaction effects on neural emotional reactivity effects of ATD depletion on the corresponding neural activity will be compared between the TPH2 genotype groups.

Neural processing during interference processing as assessed via fMRI

时间窗: 5-6h after administration of ATD, or placebo

Subjects will undergo a validated cognitive-emotional interference paradigm. To assess genotype x ATD interaction effects on neural interference control effects of ATD depletion on the corresponding neural activity will be compared between the TPH2 genotype groups.

Neural processing during the resting state as assessed via fMRI

时间窗: 5-6h after administration of ATD, or placebo

Subjects will undergo a validated resting state assessment. To assess genotype x ATD interaction effects on intrinsic brain activity in the emotion and interreference related neural networks effects of ATD depletion on the corresponding neural activity will be compared between the TPH2 genotype groups.

次要结局

  • Behavioral interference performance(5-6h after administration of ATD, or placebo)

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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