Emotional ProcessingEarly Phase 1NCT06628154
Losartan and Emotional Learning
A Early Phase 1 study testing Losartan potassium 50mg in people with Emotional Processing, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study explores the effects of single-dose losartan (50mg) versus placebo on emotional processing in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Processing
- What is being tested?
- Losartan potassium 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2024to Jul 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide informed consent
- Aged 18-50 years
- Score of or below 45 on the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015)
- Sufficient written and spoken English skills to understand what the study involves, and to complete the questionnaires
- Non- or light-smoker (5 cigarettes a day)
Who cannot join
- Past or present DSM-5 axis-I diagnosis (based on SCID results at screening) other than anxiety disorder, dysthymia or unipolar depression
- 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
- History of angioedema
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- Impaired kidney function (based on self-report)
- 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))
- Lifetime history of epilepsy or other neurological disease (e.g. autism, ADHD)
- 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 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
- Women: pregnancy, breast-feeding
Trial locations and contacts
1 site in 1 country.
Sanika Kulkarni, 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
Andrea Reinecke, PhD
About this study
Official title: The Effects of Single-dose Losartan on Cognitive Flexibility and Learning in Healthy Adults: a Randomised Controlled Study
This study explores the effects of single-dose losartan (50mg) versus placebo on emotional processing in healthy volunteers.
Read the detailed description
The renin-angiotensin system is a major hormone system involved in blood pressure regulation. However, its major receptors are also found in the brain, particularly in areas implicated in anxiety and depression. In line with this topography, drugs blocking angiotensin-II receptors have been shown to have effects on cognition that are opposite to those seen in emotional disorders. For instance, angiotensin receptor blockade improves fear extinction, and it dampens stress responsivity to highly aversive images. In line with such cognitive effects, population-based studies suggest that angiotensin receptor blockers - compared to other antihypertensive drugs - prevent the development of post-traumatic stress disorder following trauma exposition and improve outcomes in patients taking SSRI.
This study aims to shed further light on how the renin-angiotensin system affects different aspects of cognitive processing in humans relevant to emotional disorders. In a double-blind, randomized between-group design, we will investigate the effects of a single dose of losartan (50mg) versus placebo on emotional processing in N=60 healthy volunteers aged 18-50 years. Results from this study will help us understand how the renin-angiotensin system affects emotional processing in humans, and they will help us identify potential synergistic overlaps with the cognitive mechanisms of action of effective treatment of emotional disorders.
- Conditions
- Emotional Processing
- Being tested
- Losartan potassium 50mg, Placebo
- Keywords
- emotional processing, reward, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan potassium 50mgDrug
Single dose losartan (50 mg, weight-adjusted), encapsulated identically to placebo
PlaceboOther
Single tablet encapsulated identically to losartan
| Study group | Role | What they receive |
|---|---|---|
| losartan | Experimental | oral single-dose losartan potassium (Cozaar; 50mg) Receives: Drug: Losartan potassium 50mg |
| placebo | Placebo comparator | Microcellulose placebo in identical capsule Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcement Learning
reinforcement learning, calculated as the learning rate from aversive and appetitive decision outcomes. Larger scores indicate better learning from an outcome.
Measured: 1 hour after capsule intake
Secondary outcomes (3)
Cognitive Flexibility
switch cost, calculated by rank-ordering the differences between each switch trial RT and each participants average RT for all non-switch trials from 1 - 10 (with better and worse bins having values closer to 1 and 10, respectively), and then summing the bin values to compute a total bin score for each participant. Inaccurate responses are penalized by being assigned a score of 20. Smaller bin scores indicate greater accuracy and lower RT.
Measured: 1 hour after capsule intake
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: 1hour after capsule intake
Motivational effort in the Apples Task
effort valuation, calculated as the willingness to engage in physical effort to obtain rewards of certain values using the Apples Task (and computational approaches)
Measured: 1hour after capsule intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start14 Aug 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Andrea Reinecke, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628154
- Sponsor's protocol ID
- R80447
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 4 Oct 2024
- 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 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Single-dose Losartan on Cognitive Flexibility and Learning in Healthy Adults: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06628154
- Acronym / sponsor ID
- R80447
- Conditions
- Emotional Processing
- Keywords
- emotional processing, reward, anxiety, depression
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Oct 2024 (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 single-dose losartan (50mg) versus placebo on emotional processing in healthy volunteers.
Detailed description
The renin-angiotensin system is a major hormone system involved in blood pressure regulation. However, its major receptors are also found in the brain, particularly in areas implicated in anxiety and depression. In line with this topography, drugs blocking angiotensin-II receptors have been shown to have effects on cognition that are opposite to those seen in emotional disorders. For instance, angiotensin receptor blockade improves fear extinction, and it dampens stress responsivity to highly aversive images. In line with such cognitive effects, population-based studies suggest that angiotensin receptor blockers - compared to other antihypertensive drugs - prevent the development of post-traumatic stress disorder following trauma exposition and improve outcomes in patients taking SSRI.
This study aims to shed further light on how the renin-angiotensin system affects different aspects of cognitive processing in humans relevant to emotional disorders. In a double-blind, randomized between-group design, we will investigate the effects of a single dose of losartan (50mg) versus placebo on emotional processing in N=60 healthy volunteers aged 18-50 years. Results from this study will help us understand how the renin-angiotensin system affects emotional processing in humans, and they will help us identify potential synergistic overlaps with the cognitive mechanisms of action of effective treatment of emotional disorders.
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 potassium 50mgoral single-dose losartan potassium (Cozaar; 50mg) |
| placebo | Placebo comparator | Other: PlaceboMicrocellulose placebo in identical capsule |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to provide informed consent
- Aged 18-50 years
- Score of or below 45 on the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015)
- Sufficient written and spoken English skills to understand what the study involves, and to complete the questionnaires
- Non- or light-smoker (5 cigarettes a day)
Key exclusion criteria (12 listed)
- Past or present DSM-5 axis-I diagnosis (based on SCID results at screening) other than anxiety disorder, dysthymia or unipolar depression
- 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
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 potassium 50mgSingle dose losartan (50 mg, weight-adjusted), encapsulated identically to placebo | Drug | losartan |
| PlaceboSingle tablet encapsulated identically to losartan | Other | placebo |
Primary outcome
Reinforcement Learning
Time frame: 1 hour after capsule intake
reinforcement learning, calculated as the learning rate from aversive and appetitive decision outcomes. Larger scores indicate better learning from an outcome.
3 secondary outcomes
Cognitive Flexibility
Time frame: 1 hour after capsule intake
AAT effect score
Time frame: 1hour after capsule intake
Motivational effort in the Apples Task
Time frame: 1hour after capsule intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- 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. This study is not recruiting at the moment.
Sanika Kulkarni, 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 potassium 50mg in people with Emotional Processing, 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 4 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Reinecke, PhD (+44 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?
Reinforcement Learning (time frame: 1 hour after capsule intake). 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 4 Oct 2024.