Effects of losartan on emotional processing in adolescents
The Effects of Single-dose Losartan on the Processing of Emotional Information in Healthy Adolescents: a Randomised Controlled Study
This study is testing if a single dose of losartan can help healthy teens aged 16 to 17 process emotions better, especially in reducing fear, which could be useful for those with anxiety.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 16 Years to 20 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06636812 on ClinicalTrials.gov |
What this trial studies
This study investigates how a single dose of losartan, a medication typically used for high blood pressure, affects emotional processing in young healthy volunteers aged 16 to 17. The research aims to understand if losartan can enhance fear extinction, a process that is often impaired in adolescents and linked to anxiety disorders. Participants will be randomly assigned to receive either losartan or a placebo in a double-blind manner, allowing for an unbiased assessment of the drug's effects on emotional processing. The study is based on previous findings that suggest losartan may improve brain function related to anxiety treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adolescents aged 16 to 17 who are non-smokers and can attend appointments in Oxford.
Not a fit: Patients with a history of severe psychiatric illness or those currently on certain heart medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for anxiety disorders in adolescents by enhancing emotional processing.
How similar studies have performed: Previous studies have shown that losartan can enhance fear extinction in adults, suggesting potential for similar effects in adolescents, although this specific application is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oxford, Oxfordshire
- Warneford Hospital, University of Oxford — Oxford, Oxfordshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Andrea Reinecke, PhD — University of Oxford
- Study coordinator: Andrea Reinecke, PhD
- Email: andrea.reinecke@psych.ox.ac.uk
- Phone: +44 01865 618320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.