The Effect of Losartan on Emotional Processing in Healthy Volunteers

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Losartan; Other: Placebo

• Registration Number: NCT03434054
• Lead Sponsor: University of Oxford

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Study First Submitted: 2018-01-30
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan	Losartan	single dose of 50mg losartan, tablet, over-encapsulated, to be taken orally
Placebo	Placebo	single dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally

Primary Outcome Measures

Name	Time	Method
BOLD signal change	1 day	BOLD signal change during functional magnet resonance imaging (fMRI)