Clinical trial NCT03434054: The Effect of Losartan on Emotional Processing in Healthy Volunteers
Official title: The Effect of Losartan on Emotional Processing in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: losartan
emotional processing
anxiety
magnet resonance imaging
MRI
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: BOLD signal change
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Andrea Reinecke, PhD
role: STUDY_CHAIR
References:
citation: Reinecke A, Browning M, Klein Breteler J, Kappelmann N, Ressler KJ, Harmer CJ, Craske MG. Angiotensin Regulation of Amygdala Response to Threat in High-Trait-Anxiety Individuals. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Oct;3(10):826-835. doi: 10.1016/j.bpsc.2018.05.007. Epub 2018 Jun 5.