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
- Are there results?
- Not yet: the study is under way
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
Show all 23Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Losartan-augmented Behavioural Activation in Anhedonia
- ClinicalTrials.gov ID
- NCT07017023
- Acronym / sponsor ID
- CUREC reference 660982
- Conditions
- Emotional Processing, Mood
- Keywords
- emotional processing, mood
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel randomised experimental medicine trial
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartan with BA7-day losartan potassium (Cozaar; 50mg; oral tablet) with 7-day BA |
| Placebo | Placebo comparator | Other: Placebo with BA7-day placebo (oral; microcellulose in identical capsules) with 7-day BA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Losartan with BA7-day losartan (Cozaar, 50mg; oral tablet) with 7-day BA | Drug | Losartan |
| Placebo with BA7-day placebo (oral; microcellulose in identical capsules) with 7-day BA | Other | Placebo |
Primary outcome
Change in reinforcement learning
Time frame: from baseline to post 7-day intervention
reinforcement learning, calculated as the learning rate from negative and positive decision outcomes. Larger scores indicate better learning from an outcome.
3 secondary outcomes
Change in approach-avoidance-task (AAT) effect score
Time frame: from baseline to post 7-day intervention
Change in social approach decisions
Time frame: from baseline to post 7-day intervention
Change in motivational effort in the Apples Task
Time frame: from baseline to post 7-day intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rowan Haslam, MSc contact
Andrea Reinecke, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Reinecke, PhD (01865 618320, andrea.reinecke@psych.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reinforcement learning (time frame: from baseline to post 7-day intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.