The Effect of Losartan on Emotional Processing in Healthy Volunteers

NCT03434054 | Completed

• 1 other identifier: MSD-IDREC-C3-2015-832
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Keywords

losartan; emotional processing; anxiety; magnet resonance imaging; MRI

Outcome Measures

Primary Outcomes (1)

• BOLD signal change

  BOLD signal change during functional magnet resonance imaging (fMRI)

  1 day

Study Arms (2)

Losartan

EXPERIMENTAL

single dose of 50mg losartan, tablet, over-encapsulated, to be taken orally

Drug: Losartan

Placebo

PLACEBO COMPARATOR

single dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally

Other: Placebo

Interventions

Losartan DRUG

blood pressure medication

Also known as: Losartan Potassium

Losartan

Placebo OTHER

non-active sham intervention

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Related Publications (1)

• 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.

  PMID: 29980493 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Losartan

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Andrea Reinecke, PhD

  University of Oxford

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Study medication and placebo are over-encapsulated to look identical, and both the participants and investigators in direct contact with partiicpants are blind to group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 15, 2018
• Study Start: June 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02