Losartan and Social Processing

NCT06624904 | Recruiting Early Phase 1

• 1 other identifier: R92661
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study explores the effects of single-dose losartan (50mg) versus placebo on social processing in healthy volunteers.

Conditions

Social Cognition

Keywords

Social Processing; Losartan; Renin Angiotensin System

Outcome Measures

Primary Outcomes (1)

• AAT effect score

  mean reaction time of the pull trials of a valence category subtracted from the push trials of the same category, yielding a single indicator of approach/avoidance, with positive scores indicating relatively stronger approach and negative scores indicating relatively stronger avoidance

  1 hour after capsule intake

Secondary Outcomes (3)

• Sensitivity to Social Rejection

  1 hour after capsule intake

• Social Learning

  1 hour after capsule intake

• Interpretation Inflexibility

  1 hour after capsule intake

Study Arms (2)

Losartan

EXPERIMENTAL

50 mg single-dose losartan

Drug: Losartan potassium 50mg

Placebo

PLACEBO COMPARATOR

Microcellulose placebo in identical capsule

Other: Placebo

Interventions

Losartan potassium 50mg DRUG

Single dose losartan (50 mg), encapsulated identically to placebo.

Also known as: Losartan, Cozaar

Losartan

Placebo OTHER

Single tablet encapsulated identically to placebo.

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
• Aged 18-50 years
• Sufficient written and spoken English skills to understand what the study involves, and to complete the questionnaires
• Non- or light-smoker (5 cigarettes a day, if vaping: less than 50 puffs)
• BMI between 18 - 30

You may not qualify if:

• Current DSM-5 axis-I diagnosis (based on SCID results at screening) or history of a severe psychological disorder such as psychotic disorder, bipolar disorder, alcohol or substance abuse, or post-traumatic stress disorder
• First-degree family member with severe psychiatric illness (including psychosis, bipolar disorder, unipolar psychotic depression).
• CNS-medication last 6 weeks (including as part of another study)
• Current blood pressure or other heart medication, including aliskiren and beta blockers)
• Diagnosis of intravascular fluid depletion or dehydration
• History of angioedema
• Impaired kidney function (based on self-report)
• Very low blood pressure (defined as repeated (at least three consecutive measurements) measures of blood pressure under standardised conditions where either the systolic or the diastolic blood pressure or both are below 90/50 mmHg (in accordance with established standard definitions)
• Lifetime history of epilepsy or other neurological disorder, as established by a professional diagnosis (e.g. autism, ADHD)
• Lifetime history of 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
• Significant loss of hearing that is not corrected with a hearing device
• Women: pregnancy (as determined by a urine test, if the participant's pregnancy status is unknown during the in-person visit), breast-feeding

Sponsors & Collaborators

• University of Oxford: lead
• Oxford Health Biomedical Research Centre (OH BRC) support scheme: collaborator

Study Sites (1)

Warneford Hospital

Oxford, Oxfordshire, OX37JX, United Kingdom

RECRUITING

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Andrea Reinecke, PhD

CONTACT

01865 618320; andrea.reinecke@psych.ox.ac.uk

Divya Prasad, MSc

CONTACT

divya.prasad@psych.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel randomised experimental medicine trial.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 3, 2024
• Study Start: August 19, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 28, 2025

Record last verified: 2024-09

Locations

GB (1)