The Effect of Losartan on Emotional Processing in Healthy Volunteers

Study Overview
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Brief Summary
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This experimental medicine study explores whether a single dose of losartan (50mg) versus placebo affects the processing of positive and negative stimuli, using fMRI.

Detailed Description
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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.

Official Title
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The Effect of Losartan on Emotional Processing in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Losartan
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blind, placebo-controlled experimental medicine study, where healthy volunteers are randomised to receiving either a single dose of losartan (50mg) or matching placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan<br>single dose of 50mg losartan, tablet, over-encapsulated, to be taken orally | Drug: Losartan<br>* blood pressure medication<br>* Other names: Losartan Potassium;|
| Placebo Comparator: Placebo<br>single dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally | Other: Placebo<br>* non-active sham intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD signal change | BOLD signal change during functional magnet resonance imaging (fMRI) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, losartan, emotional processing, anxiety, magnet resonance imaging