The Effect of Losartan on Emotional Processing in Healthy Volunteers
研究概览
详细说明
Losartan has been shown to accelerate fear extinction in animals and to prevent the development of anxiety disorders in humans, emphasising its potential to possibly enhance exposure therapy in humans. This study explores the basic effects of losartan on emotional processing, to identify neural mechanisms by which the drug might have synergistic effects on psychological treatment in humans.
In a double-blind between-groups design, 30 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo, and this study will measure the effects of probing renin-angiotensin function on emotional information processing, using functional magnet resonance imaging (fMRI). Such knowledge will ultimately be essential for the development of more effective pharmaco-psychological treatment approaches for anxiety disorders.
研究类型
注册 (实际的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- willing and able to provide informed consent
- male or Female, aged 18-50
- body mass index (BMI) of 18-30 kg/m2
- fluent English skills
- non- or light-smoker (< 5 cigarettes a day)
Exclusion Criteria:
- Female participant who is pregnant or breast-feeding
- central nervous system (CNS) active medication during the last 6 weeks
- Current blood pressure/other heart medication (esp. aliskiren or beta blockers)
- Intravascular fluid depletion
- Past or present DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) axis-I diagnosis
- Alcohol or substance abuse
- First-degree family member with a history of a severe psychiatric disease
- Impaired liver or kidney function
- Lifetime history of epilepsy or other neurological disease, systemic infection, or clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, endocrine or pulmonary disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Insufficient English skills
- participated in another study involving certain medication during last 6 weeks
- Contraindication to magnet resonance imaging (MRI) scanning (e.g. pacemaker)
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Losartan
single dose of 50mg losartan, tablet, over-encapsulated, to be taken orally
|
blood pressure medication
其他名称：
|
|
安慰剂比较：Placebo
single dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally
|
non-active sham intervention
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BOLD signal change
大体时间：1 day
|
BOLD signal change during functional magnet resonance imaging (fMRI)
|
1 day
|
合作者和调查者
调查人员
- 学习椅：Andrea Reinecke, PhD、University of Oxford
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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