The Effect of Losartan on Emotional Processing in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

The Effect of Losartan on Emotional Processing in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434054
• Other study ID #: MSD-IDREC-C3-2015-832
• Status: Completed
• Phase: N/A
• First received: January 30, 2018
• Last updated: February 15, 2018
• Start date: June 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: February 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Losartan
blood pressure medication

Other:
• Placebo
non-active sham intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal change	BOLD signal change during functional magnet resonance imaging (fMRI)	1 day