Healthy VolunteersNCT03434054
The Effect of Losartan on Emotional Processing in Healthy Volunteers
A study testing Losartan in people with Healthy Volunteers, run by University of Oxford.
Trial summary
This experimental medicine study explores whether a single dose of losartan (50mg) versus placebo affects the processing of positive and negative stimuli, using fMRI. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Jun 2017
- 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
- central nervous system (CNS) active medication during the last 6 weeks
- Current blood pressure/other heart medication (esp. aliskiren or beta blockers)
- Intravascular fluid depletion
- Past or present DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) axis-I diagnosis
- Alcohol or substance abuse
Show all 12Show 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 certain medication during last 6 weeks
- Contraindication to magnet resonance imaging (MRI) scanning (e.g. pacemaker)
About this study
This experimental medicine study explores whether a single dose of losartan (50mg) versus placebo affects the processing of positive and negative stimuli, using fMRI.
Read the detailed description
Losartan has been shown to accelerate fear extinction in animals and to prevent the development of anxiety disorders in humans, emphasising its potential to possibly enhance exposure therapy in humans. This study explores the basic effects of losartan on emotional processing, to identify neural mechanisms by which the drug might have synergistic effects on psychological treatment in humans.
In a double-blind between-groups design, 30 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo, and this study will measure the effects of probing renin-angiotensin function on emotional information processing, using functional magnet resonance imaging (fMRI). Such knowledge will ultimately be essential for the development of more effective pharmaco-psychological treatment approaches for anxiety disorders.
- Conditions
- Healthy Volunteers
- Being tested
- Losartan, Placebo
- Keywords
- losartan, emotional processing, anxiety, magnet resonance imaging, MRI
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Losartan Potassium
blood pressure medication
PlaceboOther
non-active sham intervention
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | single dose of 50mg losartan, tablet, over-encapsulated, to be taken orally Receives: Drug: Losartan |
| Placebo | Placebo comparator | single dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal change
BOLD signal change during functional magnet resonance imaging (fMRI)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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 Healthy VolunteersStudies 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
- This is a double-blind, placebo-controlled experimental medicine study, where healthy volunteers are randomised to receiving either a single dose of losartan (50mg) or matching placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Reinecke, PhD, Study chair, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434054
- Sponsor's protocol ID
- MSD-IDREC-C3-2015-832
- Status last verified
- Feb 2018
- First submitted
- 30 Jan 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Reinecke A, Browning M, Klein Breteler J, Kappelmann N, Ressler KJ, Harmer CJ, Craske MG. Angiotensin Regulation of Amygdala Response to Threat in High-Trait-Anxiety Individuals. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Oct;3(10):826-835. doi: 10.1016/j.bpsc.2018.05.007. Epub 2018 Jun 5.
PubMed 29980493
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Losartan on Emotional Processing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03434054
- Acronym / sponsor ID
- MSD-IDREC-C3-2015-832
- Conditions
- Healthy Volunteers
- Keywords
- losartan, emotional processing, anxiety, magnet resonance imaging, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 15 Feb 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 experimental medicine study explores whether a single dose of losartan (50mg) versus placebo affects the processing of positive and negative stimuli, using fMRI.
Detailed description
Losartan has been shown to accelerate fear extinction in animals and to prevent the development of anxiety disorders in humans, emphasising its potential to possibly enhance exposure therapy in humans. This study explores the basic effects of losartan on emotional processing, to identify neural mechanisms by which the drug might have synergistic effects on psychological treatment in humans.
In a double-blind between-groups design, 30 healthy volunteers will be randomised to a group receiving a single dose of losartan (50mg) versus placebo, and this study will measure the effects of probing renin-angiotensin function on emotional information processing, using functional magnet resonance imaging (fMRI). Such knowledge will ultimately be essential for the development of more effective pharmaco-psychological treatment approaches for 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
- This is a double-blind, placebo-controlled experimental medicine study, where healthy volunteers are randomised to receiving either a single dose of losartan (50mg) or matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartansingle dose of 50mg losartan, tablet, over-encapsulated, to be taken orally |
| Placebo | Placebo comparator | Other: Placebosingle dose of placebo (main ingredient microcrystalline cellulose), tablet, over-encapsulated, to be taken orally |
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 (12 listed)
- Female participant who is pregnant or breast-feeding
- central nervous system (CNS) active medication during the last 6 weeks
- Current blood pressure/other heart medication (esp. aliskiren or beta blockers)
- Intravascular fluid depletion
- Past or present DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) axis-I diagnosis
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 |
|---|---|---|
| LosartanAlso: Losartan Potassiumblood pressure medication | Drug | Losartan |
| Placebonon-active sham intervention | Other | Placebo |
Primary outcome
BOLD signal change
Time frame: 1 day
BOLD signal change during functional magnet resonance imaging (fMRI)
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 19 Feb 2018.
- Derived from this study: PubMed 29980493Reinecke A, Browning M, Klein Breteler J, Kappelmann N, Ressler KJ, Harmer CJ, Craske MG. Angiotensin Regulation of Amygdala Response to Threat in High-Trait-Anxiety Individuals. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Oct;3(10):826-835. doi: 10.1016/j.bpsc.2018.05.007. Epub 2018 Jun 5.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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 study chair
University of Oxford
Questions about this trial
What is this clinical trial studying?
A study testing Losartan in people with Healthy Volunteers, run by University of Oxford.
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: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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 signal change (time frame: 1 day). 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 NCT03434054, 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 19 Feb 2018.