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临床试验/NCT04606225
NCT04606225Unknown不适用

The Role of the Renin-angiotensin System in Emotion-memory Interactions

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年10月10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
60
试验地点
1
主要终点
fMRI-based indices of neural activity during processing of emotional stimuli will be compared between the treatment groups

研究概览

简要总结

The purpose of this study is to investigate whether a single dose of losartan (50 mg) can affect emotion-memory interaction in healthy humans and its underlying neural mechanisms.

详细描述

Animal models and initial findings in humans suggest a role of the renin-angiotensin system in cognitive and emotional processes. Accumulating evidence demonstrates modulatory effects of the angiotensin antagonist losartan in the domains of memory and emotional processing. Against this background the present study aims to investigate the behavioral and neural effects of a single dose of losartan on emotional processing and emotion-memory integration in healthy subjects. In a double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment, 60 male participants will be randomized to a single dose of losartan (50 mg) or placebo, and encode emotional pictures during fMRI (scheduled 90 minutes after drug administration). Then 24 hours post fMRI participants will finish a surprise recognition memory test to estimate the emotion effects on subsequent memory.

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
  • Normal or corrected-normal version

排除标准

  • History of head injury
  • Medical or psychiatric illness
  • Hypertension
  • General cardio-vascular alteration or diseases
  • Allergy against medications
  • Visual or motor impairments
  • Claustrophobia
  • Drug addiction
  • Nicotine dependence
  • FMRI contradictions

研究组 & 干预措施

Losartan group

Experimental

Drug: Losartan

干预措施: Losartan (Drug)

Placebo group

Placebo Comparator

Drug: Placebo Oral Tablet

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

fMRI-based indices of neural activity during processing of emotional stimuli will be compared between the treatment groups

时间窗: 120 to 150 minutes after treatment

Neural activation during processing of emotional pictures will be assessed by functional magnetic resonance imaging (fMRI). The fMRI data will be analyzed by a Generalized Linear Model approach. Effects of treatment will be determined by comparing the losartan-treated group with the placebo-treated group.

fMRI-based indices of neural activity for subsequently successfully remembered as compared to non-remembered stimuli will be compared between the treatment groups

时间窗: 120 to 150 minutes after treatment

Neural activation for stimuli that are successfully remembered after an interval of 24hours will be compared to stimuli that are not successfully remembered. Neural activity between the subsequently remembered and non-remembered stimuli will be assessed by functional magnetic resonance imaging (fMRI) acquired during the initial encoding of the stimuli. The fMRI data will be analyzed by a Generalized Linear Model approach. Effects of treatment will be determined by comparing the losartan-treated group with the placebo-treated group.

次要结局

  • Self-Assessment Manikin (SAM) ratings of arousal of the stimuli will be compared between the treatment groups(120 to 150 minutes after treatment)
  • Self-Assessment Manikin (SAM) ratings of valence of the stimuli will be compared between the treatment groups(120 to 150 minutes after treatment)
  • Memory performance in terms of correctly recognized stimuli will be compared between the treatment groups(24 hours after treatment)

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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