MemoryNCT03763409
Losartan and Emotional Memory
A study testing Losartan Potassium in people with Memory and Learning, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study explores the effects of single-dose losartan (50mg) versus identical placebo capsule on emotional memory and learning in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- 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
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 28 Sep 2018
- 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
- body mass index (BMI) of 18-30 kg/m2
- fluent English skills
- non- or light-smoker (< 5 cigarettes a day)
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)
- Intravascular fluid depletion
- Past or present DSM-IV axis-I diagnosis or suspected diagnosis (from SCID results at screening)
- Alcohol or substance abuse
Show all 11Show fewer
- 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.
- Insufficient English skills
- participated in another study involving CNS-active medication during the last 6 weeks
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 Emotional Memory in Healthy Volunteers
This study explores the effects of single-dose losartan (50mg) versus identical placebo capsule on emotional memory and learning in healthy volunteers.
Read the detailed description
The commonly prescribed antihypertensive drug losartan (brand name: Cozaar; UK licensed for 20 years) targets the renin-angiotensin system - a hormone system regulating blood pressure - by acting as an angiotensin receptor antagonist. In particular, 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 symptoms following trauma exposition. Such results suggest that the renin-angiotensin system plays a key role in the development and extinction of anxiety, and that adding losartan to cognitive-behavioural therapy for anxiety in humans might have synergistic effects. However, it remains to be clarified what the basic effects of this drug on emotional information processing in humans are to identify mechanisms by which it may improve psychological treatments.
In this study, the key neuropsychological effects of probing the renin-angiotensin system on emotional information processing and learning will be investigated. In a double-blind, randomised between-groups design, 54 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo. When peak plasma levels are reached, participants will work on a battery of behavioural measures of emotional information processing and learning.
The results from this study will help understand how the renin-angiotensin system affects emotional information processing and learning, and they will help 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.
- Being tested
- Losartan Potassium, placebo
- Keywords
- anxiety, losartan, appetitive learning, aversive learning
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan PotassiumDrug
active drug
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| losartan | Experimental | 50 mg single-dose oral losartan Receives: Drug: Losartan Potassium |
| 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.
aversive and appetitive learning
a learning task wil assess to what degree participants learn from win versus loss outcomes in different environments
Measured: 1 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 posted4 Dec 2018
- Study start1 Mar 2018
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MemoryStudies 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
- Parallel randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763409
- Sponsor's protocol ID
- R56384/RE001
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pulcu E, Shkreli L, Holst CG, Woud ML, Craske MG, Browning M, Reinecke A. The Effects of the Angiotensin II Receptor Antagonist Losartan on Appetitive Versus Aversive Learning: A Randomized Controlled Trial. Biol Psychiatry. 2019 Sep 1;86(5):397-404. doi: 10.1016/j.biopsych.2019.04.010. Epub 2019 Apr 17.
PubMed 31155138
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Losartan on Emotional Memory in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03763409
- Acronym / sponsor ID
- R56384/RE001
- Keywords
- anxiety, losartan, appetitive learning, aversive learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 4 Dec 2018 (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 identical placebo capsule on emotional memory and learning in healthy volunteers.
Detailed description
The commonly prescribed antihypertensive drug losartan (brand name: Cozaar; UK licensed for 20 years) targets the renin-angiotensin system - a hormone system regulating blood pressure - by acting as an angiotensin receptor antagonist. In particular, 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 symptoms following trauma exposition. Such results suggest that the renin-angiotensin system plays a key role in the development and extinction of anxiety, and that adding losartan to cognitive-behavioural therapy for anxiety in humans might have synergistic effects. However, it remains to be clarified what the basic effects of this drug on emotional information processing in humans are to identify mechanisms by which it may improve psychological treatments.
In this study, the key neuropsychological effects of probing the renin-angiotensin system on emotional information processing and learning will be investigated. In a double-blind, randomised between-groups design, 54 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo. When peak plasma levels are reached, participants will work on a battery of behavioural measures of emotional information processing and learning.
The results from this study will help understand how the renin-angiotensin system affects emotional information processing and learning, and they will help 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
- Parallel randomised
| Arm | Type | Receives |
|---|---|---|
| losartan | Experimental | Drug: Losartan Potassium50 mg single-dose oral losartan |
| 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
- male or Female, aged 18-50
- body mass index (BMI) of 18-30 kg/m2
- fluent English skills
- non- or light-smoker (< 5 cigarettes a day)
Key exclusion criteria (11 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)
- Intravascular fluid depletion
- 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 Potassiumactive drug | Drug | losartan |
| placeboplacebo | Other | placebo |
Primary outcome
aversive and appetitive learning
Time frame: 1 hour after capsule intake
a learning task wil assess to what degree participants learn from win versus loss outcomes in different environments
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 6 Dec 2018.
- Derived from this study: PubMed 31155138Pulcu E, Shkreli L, Holst CG, Woud ML, Craske MG, Browning M, Reinecke A. The Effects of the Angiotensin II Receptor Antagonist Losartan on Appetitive Versus Aversive Learning: A Randomized Controlled Trial. Biol Psychiatry. 2019 Sep 1;86(5):397-404. doi: 10.1016/j.biopsych.2019.04.010. Epub 2019 Apr 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Memory and Learning, 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 11 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 6 Dec 2018. 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?
aversive and appetitive 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?
On the ClinicalTrials.gov record for NCT03763409, which also lists 1 linked publication.
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 6 Dec 2018.