Losartan and Emotional Processing in Young People

NCT06636812 | Recruiting Early Phase 1 DMC

• 1 other identifier: R79545
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Emotional Processing

Keywords

emotional processing; anxiety; adolescents

Outcome Measures

Primary Outcomes (1)

• Fear Extinction

  fear extinction score, computed as a 5-point Likert scale valence rating (1=unpleasant-5=pleasant) of the CS+ stimulus at the end of extinction minus at the end of acquisition, with larger scores indicating better fear extinction

  1 hour after capsule intake

Secondary Outcomes (4)

• Pattern Separation

  1 hour after capsule intake

• Cognitive Flexibility

  1 hour after capsule intake

• Reinforcement Learning

  1 hour after capsule intake

• Faces Dot Probe Task

  1 hour after capsule intake

Study Arms (2)

losartan

EXPERIMENTAL

single-dose losartan potassium (Cozaar; weight-adjusted 25mg or 50mg)

Drug: Losartan potassium

Placebo

PLACEBO COMPARATOR

Microcellulose placebo in identical capsule

Other: Placebo

Interventions

Losartan potassium DRUG

Single dose losartan (25mg or 50 mg, weight-adjusted), encapsulated identically to placebo

losartan

Placebo OTHER

Single tablet encapsulated identically to placebo

Placebo

Eligibility Criteria

• Age: 16 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willing and able to provide informed consent (for 16 and 17 year olds: assent and parental/ legal guardian consent)
• Non- or light-smoker (\< 5 cigarettes a day)
• Ability to attend appointments in Oxford with reasonable travel costs
• Ability/ willingness to provide GP contact details

You may not qualify if:

• Past or present DSM-5 axis-I diagnosis (based on SCID results at screening), especially severe psychiatric illness or alcohol or substance dependence
• First-degree family member with severe psychiatric illness
• CNS-medication last 6 weeks (including as part of another study)
• Current blood pressure or other heart medication (especially aliskiren or beta blockers)
• Diagnosis of intravascular fluid depletion or dehydration
• Impaired kidney function (based on blood test at screening, cut-off 75 ml/min/1.73 m2)
• Significant hyperkalaemia (level\>=6mEq/L in the absence of sample haemolysis will be considered significant hyperkalaemia)
• 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: DOI 10.1186/s12887-016-0633-7))
• Body weight below 35kg (as the lower dose of 25mg of losartan only indicated from 35kg)
• Lifetime history of epilepsy or other neurological disease (e.g. ADHD, autism)
• Lifetime history of angioedema, renal artery stenosis, valvular heart disease, recurrent postural/ orthostatic hypotension
• Lifetime history ofsystemic 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 Insufficient written and/or spoken English skills
• Women: pregnancy, breast-feeding

Sponsors & Collaborators

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

Study Sites (1)

Warneford Hospital, University of Oxford

Oxford, Oxfordshire, OX37JX, United Kingdom

RECRUITING

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Reinecke, PhD

CONTACT

+44 01865 618320; andrea.reinecke@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 15, 2024
• Study Start: March 7, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2024-09

Locations

GB (1)