PTSDNCT05828940
Losartan and Memory
A study testing Losartan Potassium in people with PTSD, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study investigates the effect of a single dose of 50mg losartan vs placebo on BOLD signal during memory encoding. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Losartan Potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2019to 31 Mar 2022
- Phase
- Interventional
- 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
- male or Female, aged 18-50 years
- body mass index (BMI) of 18-30 kg/m2
- non- or light-smoker (< 5 cigarettes a day)
- STAIT score of at least 40
Who cannot join
- Female participant who is pregnant or breast-feeding
- CNS-active medication during the last 6 weeks
- Current blood pressure or other heart medication (especially aliskiren or beta blockers)
- Diagnosis of intravascular fluid depletion or dehydration
- Past or present DSM-IV axis-I diagnosis or suspected diagnosis (from SCID results at screening)
- Alcohol or substance abuse
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- First-degree family member with a history of a severe psychiatric disease
- Impaired liver or kidney function
- Lifetime history of epilepsy or other neurological disease, 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.
- High or moderate risk of coronavirus, based on the NHS checklist for coronavirus vulnerability https://www.nhs.uk/conditions/coronavirus-covid-19/people-at-higher-risk/whos-at-higher-risk-from-coronavirus/
- Contraindication to MRI (e.g. metal implant)
- Insufficient English skills
- participated in another study involving CNS-active medication during the last 6 weeks Participants will also not be able to take part if they are left-handed, due to the research MRI aspect of the study relying on group means.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Psychiatry, University of Oxford
Oxford, OX37JX
About this study
Official title: The Effect of Losartan on Emotion Regulation
This study investigates the effect of a single dose of 50mg losartan vs placebo on BOLD signal during memory encoding.
Read the detailed description
The commonly prescribed antihypertensive drug losartan targets the renin-angiotensin system - a hormone system regulating blood pressure - by acting as an angiotensin receptor antagonist. The drug prevents a docking of the protein angiotensin IV to AT1 receptors, which leads to a dilation if vessels and a reduction in blood pressure. However, the increase in free angiotensin IV has also been associated with an increase in synaptic plasticity, the cellular mechanism involved in learning and memory. As such, losartan appears to have cognition-enhancing properties, in a way that a single dose of 50mg improves prospective memory in healthy humans . However, preliminary pre-clinical results also suggest that a single injection of the drug improves fear extinction in rodents, which is the equivalent to human cognitive-behavioural therapy for anxiety disorders . Furthermore, compared to other antihypertensive drugs, regular losartan treatment appears to prevent the development of post-traumatic stress disorder following trauma exposition . Such results suggest that the renin-angiotensin system may play a key role in the prevention of anxiety.
In this study, we investigate the effect kof probing the renin-angiotensin system on memory encoding, which has previously been shown to be impaired in PTSD. In a double-blind, randomised between-groups design, 40 healthy volunteers with moderate to high levels of trait anxiety are randomised to a group receiving a single dose of losartan (50mg) versus placebo. When peak plasma levels are reached, participants work on a battery of behavioural and neural measures of emotional information processing. These tasks will include an fMRI task where participants will see images of animals and landscapes on the screen and categorise these accordingly, to be tested for memory for these images in a later task.
The results from this study will help us understand how the renin-angiotensin system affects memory formation, and they will help us establish a battery of tasks that sensitively respond to such manipulations. Such information will ultimately lead to the development of losartan and similar agents for the more effective and more compact treatment of anxiety disorders.
- Conditions
- PTSD
- Being tested
- Losartan Potassium, Placebo
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan PotassiumDrug
oral tablet, over-encapsulated
PlaceboDrug
oral tablet, over-encapuslated
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | microcellulose Receives: Drug: Placebo |
| losartan | Experimental | 50mg losartan (Cozaar) Receives: Drug: Losartan Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD activation in hippocampus during new>familiar contrast
Measured: one hour after capsule intake
Secondary outcomes (2)
BOLD activation in other brain areas
Measured: one hour after capsule intake
pattern similarity
Measured: one hour 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 posted25 Apr 2023
- Study start1 Oct 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised double-blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Reinecke, PhD, Principal investigator, Unoversity of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828940
- Sponsor's protocol ID
- R58494/RE003
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared upon reasonable request, and within the conditions of our ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Losartan on Emotion Regulation
- ClinicalTrials.gov ID
- NCT05828940
- Acronym / sponsor ID
- R58494/RE003
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Apr 2023 (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 investigates the effect of a single dose of 50mg losartan vs placebo on BOLD signal during memory encoding.
Detailed description
The commonly prescribed antihypertensive drug losartan targets the renin-angiotensin system - a hormone system regulating blood pressure - by acting as an angiotensin receptor antagonist. The drug prevents a docking of the protein angiotensin IV to AT1 receptors, which leads to a dilation if vessels and a reduction in blood pressure. However, the increase in free angiotensin IV has also been associated with an increase in synaptic plasticity, the cellular mechanism involved in learning and memory. As such, losartan appears to have cognition-enhancing properties, in a way that a single dose of 50mg improves prospective memory in healthy humans . However, preliminary pre-clinical results also suggest that a single injection of the drug improves fear extinction in rodents, which is the equivalent to human cognitive-behavioural therapy for anxiety disorders . Furthermore, compared to other antihypertensive drugs, regular losartan treatment appears to prevent the development of post-traumatic stress disorder following trauma exposition . Such results suggest that the renin-angiotensin system may play a key role in the prevention of anxiety.
In this study, we investigate the effect kof probing the renin-angiotensin system on memory encoding, which has previously been shown to be impaired in PTSD. In a double-blind, randomised between-groups design, 40 healthy volunteers with moderate to high levels of trait anxiety are randomised to a group receiving a single dose of losartan (50mg) versus placebo. When peak plasma levels are reached, participants work on a battery of behavioural and neural measures of emotional information processing. These tasks will include an fMRI task where participants will see images of animals and landscapes on the screen and categorise these accordingly, to be tested for memory for these images in a later task.
The results from this study will help us understand how the renin-angiotensin system affects memory formation, and they will help us establish a battery of tasks that sensitively respond to such manipulations. Such information will ultimately lead to the development of losartan and similar agents for the more effective and more compact treatment of anxiety disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomised double-blind
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebomicrocellulose |
| losartan | Experimental | Drug: Losartan Potassium50mg losartan (Cozaar) |
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
- male or Female, aged 18-50 years
- body mass index (BMI) of 18-30 kg/m2
- non- or light-smoker (< 5 cigarettes a day)
- STAIT score of at least 40
Key exclusion criteria (13 listed)
- Female participant who is pregnant or breast-feeding
- CNS-active medication during the last 6 weeks
- Current blood pressure or other heart medication (especially aliskiren or beta blockers)
- Diagnosis of intravascular fluid depletion or dehydration
- Past or present DSM-IV axis-I diagnosis or suspected diagnosis (from SCID results at screening)
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 Potassiumoral tablet, over-encapsulated | Drug | losartan |
| Placebooral tablet, over-encapuslated | Drug | placebo |
Primary outcome
BOLD activation in hippocampus during new>familiar contrast
Time frame: one hour after capsule intake
2 secondary outcomes
BOLD activation in other brain areas
Time frame: one hour after capsule intake
pattern similarity
Time frame: one hour after capsule intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No. Data may be shared upon reasonable request, and within the conditions of our ethics approval.
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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.
Andrea Reinecke, PhD principal investigator
Unoversity of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Losartan Potassium in people with PTSD, 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 13 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: finished, as of the sponsor's last update on 27 Apr 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD activation in hippocampus during new>familiar contrast (time frame: one 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 27 Apr 2023.