Losartan plus activity scheduling for low positive mood
Cognitive Effects of Losartan-augmented Behavioural Activation in Anhedonia
This study tests whether seven days of losartan taken with a short behavioural activation program helps people with low positive mood process positive information better than placebo.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT07017023 on ClinicalTrials.gov |
What this trial studies
In a double-blind, randomized design, 76 adults with low positive mood will receive seven days of daily losartan 50 mg or matched placebo while completing a brief behavioural activation (BA) programme. Participants will complete computer-based cognitive tasks measuring processing of positive and negative information before and after the intervention. The trial focuses on whether pharmacologically enhancing positive information processing with losartan can boost response to BA in people who show low positive mood. All participants must be 18–65, English-speaking, and have access to a computer and reliable internet.
Who should consider this trial
Good fit: Adults aged 18–65 who report low levels of positive mood, have normal or corrected vision and hearing, can read and speak English, have access to a computer and reliable internet, and are not taking excluded medications or receiving BA already.
Not a fit: People currently on antidepressants or other CNS medications, with severe depression (BDI-II >30), active suicidal risk, history of psychosis or bipolar disorder, recent substance dependence, or recent CBT with BA are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, combining losartan with behavioural activation could improve how people with low positive mood respond to therapy by enhancing processing of positive information.
How similar studies have performed: Prior work in healthy volunteers has shown losartan can improve processing of positive stimuli, but combining losartan with behavioural activation in people with low positive mood is a novel clinical application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to provide informed consent * Aged 18-65 years * Self-reported low levels of positive mood * Sufficient written and spoken English skills to understand study procedures * Normal or corrected to normal vision and hearing * Access to a computer and reliable internet connection Exclusion Criteria: * Antidepressant treatment or medication in last three months * Currently receiving cognitive-behavioural therapy with behavioural activation * History of psychosis or bipolar disorder * History of substance dependence * Use of illegal drugs in last 3 months * First-degree relative with history of psychosis or bipolar disorder * Current or past hospitalisation for mental health reasons * BDI-II score \>30 * Judged to be currently at clinical risk of suicide * Past suicide attempt * CNS-medication last 6 weeks (including in another study) * Severely underweight or overweight in a manner that renders them unsuitable for the study in the opinion of the study medic * Current blood pressure or other heart medication * Diagnosis of intravascular fluid depletion or dehydration * History of angioedema * Impaired kidney function (based on self-report) * Very low blood pressure following established definitions (at least three consecutive measurements of blood pressure under standardised conditions where either the systolic or the diastolic blood pressure or both are below 90/60 mmHg (in accordance with established standard definitions: https://www.nhs.uk/cond...-pressure-hypotension/) * Current diagnosis of a developmental disorder (e.g. ADHD, Tourette's syndrome, severe learning disability) according to self-report, where in the opinion of the study team such difficulties would likely interfere with compliance or task performance * Current diagnosis of a neurological disorder (e.g. epilepsy, MS) according to self-report * 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 put the participant at risk when participating, or may influence compliance or task performance * Pregnancy (urine pregnancy test during Baseline Visit), breast feeding or plans to become pregnant during study participation * Heavy use of cigarettes (smoke \> 20 cigarettes per day) * Severe lactose intolerance (due to losartan containing some lactose monohydrate)
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: 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.