- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03434054
The Effect of Losartan on Emotional Processing in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan
single dose of 50mg losartan, tablet, over-encapsulated, to be taken orally
|
blood pressure medication
Other Names:
|
Placebo Comparator: Placebo
single dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally
|
non-active sham intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD signal change
Time Frame: 1 day
|
BOLD signal change during functional magnet resonance imaging (fMRI)
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrea Reinecke, PhD, University of Oxford
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSD-IDREC-C3-2015-832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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