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Completed

NCT Number: NCT03434054

The Effect of Losartan on Emotional Processing in Healthy Volunteers

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Losartan

Drug

blood pressure medication

Other names: Losartan Potassium

Placebo

Other

non-active sham intervention

Primary outcomes

  1. BOLD signal change

    Time frame: 1 day

    BOLD signal change during functional magnet resonance imaging (fMRI)

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2018
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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