Losartan and Memory

NCT05828940 | Completed

• 1 other identifier: R58494/RE003
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of a single dose of 50mg losartan vs placebo on BOLD signal during memory encoding.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• BOLD activation in hippocampus during new>familiar contrast

  one hour after capsule intake

Secondary Outcomes (2)

• BOLD activation in other brain areas

  one hour after capsule intake

• pattern similarity

  one hour after capsule intake

Study Arms (2)

placebo

PLACEBO COMPARATOR

microcellulose

Drug: Placebo

losartan

EXPERIMENTAL

50mg losartan (Cozaar)

Drug: Losartan Potassium

Interventions

Losartan Potassium DRUG

oral tablet, over-encapsulated

losartan

Placebo DRUG

oral tablet, over-encapuslated

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 years
• body mass index (BMI) of 18-30 kg/m2
• non- or light-smoker (\< 5 cigarettes a day)
• STAIT score of at least 40

You may not qualify if:

• Female participant who is pregnant or breast-feeding
• CNS-active medication during the last 6 weeks
• Current blood pressure or other heart medication (especially aliskiren or beta blockers)
• Diagnosis of intravascular fluid depletion or dehydration
• Past or present DSM-IV axis-I diagnosis or suspected diagnosis (from SCID results at screening)
• 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.
• High or moderate risk of coronavirus, based on the NHS checklist for coronavirus vulnerability https://www.nhs.uk/conditions/coronavirus-covid-19/people-at-higher-risk/whos-at-higher-risk-from-coronavirus/
• Contraindication to MRI (e.g. metal implant)
• Insufficient English skills
• participated in another study involving CNS-active medication during the last 6 weeks Participants will also not be able to take part if they are left-handed, due to the research MRI aspect of the study relying on group means.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, OX37JX, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Losartan

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; 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

  Unoversity of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised double-blind

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: October 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)