Emotional ProcessingEarly Phase 1NCT07017023
Combined Blood Pressure Medication and Activity Scheduling for Low Mood
A Early Phase 1 study testing Losartan with BA in people with Emotional Processing and Mood, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study explores the effects of 7-day losartan (50mg) versus placebo with brief behavioural activation on emotional processing in young volunteers low in positive mood Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Processing, Mood
- What is being tested?
- Losartan with BA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jul 2025to 31 Dec 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rowan Haslam, MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Warneford Hospital, University of Oxford
Oxford, Oxfordshire, OX37JX
Andrea Reinecke, PhD, 01865 618320, andrea.reinecke@psych.ox.ac.uk
Rowan Haslam, MSc, rowan.haslam@psych.ox.ac.uk
About this study
Official title: Cognitive Effects of Losartan-augmented Behavioural Activation in Anhedonia
This study explores the effects of 7-day losartan (50mg) versus placebo with brief behavioural activation on emotional processing in young volunteers low in positive mood
Read the detailed description
Behavioural Activation (BA) is a first-line treatment for depression that aims to re-engage patients with rewarding activities, to improve mood. However, patients with low levels of positive mood respond less well to BA than others. Neuroscience has identified deficits in the processing of positive stimuli in this group of people, using cognitive-psychological computer tasks and brain imaging. Losartan, a licensed medication targeting the renin-angiotensin system, has recently been found to improve the processing of positive stimuli in healthy volunteers. Combining losartan with BA may improve treatment response in people with low positive mood, by improving positive information processing. This study will test this hypothesis.
In a double-blind randomised trial, 76 participants with low positive mood will receive 7-day behavioural activation (BA) with daily losartan (50mg) or placebo. Before and after the intervention, they will complete computer tasks measuring processing of positive and negative information.
- Conditions
- Emotional Processing, Mood
- Being tested
- Losartan with BA, Placebo with BA
- Keywords
- emotional processing, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan with BADrug
7-day losartan (Cozaar, 50mg; oral tablet) with 7-day BA
Placebo with BAOther
7-day placebo (oral; microcellulose in identical capsules) with 7-day BA
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | 7-day losartan potassium (Cozaar; 50mg; oral tablet) with 7-day BA Receives: Drug: Losartan with BA |
| Placebo | Placebo comparator | 7-day placebo (oral; microcellulose in identical capsules) with 7-day BA Receives: Other: Placebo with BA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reinforcement learning
reinforcement learning, calculated as the learning rate from negative and positive decision outcomes. Larger scores indicate better learning from an outcome.
Measured: from baseline to post 7-day intervention
Secondary outcomes (3)
Change in approach-avoidance-task (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
Measured: from baseline to post 7-day intervention
Change in social approach decisions
% approach vs avoid decisions
Measured: from baseline to post 7-day intervention
Change in motivational effort in the Apples Task
The task weighs effort costs against reward value. It involves a hand dynamometer to record effort. On each trial, participants receive an offer showing a reward (number of apples shown on a tree) and an effort level (height of marking on the tree trunk), which they can accept or reject (Yes/No response). On a subset of accepted trials, participants have to exert physical effort on the hand dynamometer to earn the reward (number of apples in the respective trial). Participants receive monetary reward for the number of apples collected. Key outcome marker is effort-reward valuation, i.e. % accepted trials based on combinations of effort and reward levels. Other outcomes: Force exerted relative to Maximum Voluntary Contraction (MVC), Reaction times of Yes/No.
Measured: from baseline to post 7-day intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start8 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional ProcessingStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomised experimental medicine trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Reinecke, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017023
- Sponsor's protocol ID
- CUREC reference 660982
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided