Losartan and Emotional Processing in Young People

Launched by UNIVERSITY OF OXFORD · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called losartan affects emotional processing in young, healthy volunteers. Specifically, researchers want to see if a single dose of losartan (50 mg) can change how people understand and react to emotions compared to a placebo, which is a harmless pill that looks just like the medication but has no active ingredients. The trial is currently looking for participants aged 18 to 25, and both men and women can join.

To be eligible for this study, participants must be able to provide consent and should not smoke much (less than five cigarettes a day). They must also be able to attend appointments in Oxford and provide contact information for their doctor. However, individuals with certain serious health conditions, past psychiatric issues, or those on specific medications cannot participate. If you join the study, you will take either losartan or a placebo and be monitored for how this affects your emotional processing. This research could help us understand better ways to support emotional health in young people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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