Social CognitionEarly Phase 1NCT06624904
Losartan and Social Processing
A Early Phase 1 study testing Losartan potassium 50mg in people with Social Cognition, 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 social 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
- Social Cognition
- 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
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2024to 1 Oct 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
- 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, if vaping: less than 50 puffs)
- BMI between 18 - 30
Who cannot join
- Current DSM-5 axis-I diagnosis (based on SCID results at screening) or history of a severe psychological disorder such as psychotic disorder, bipolar disorder, alcohol or substance abuse, or post-traumatic stress disorder
- First-degree family member with severe psychiatric illness (including psychosis, bipolar disorder, unipolar psychotic depression).
- CNS-medication last 6 weeks (including as part of another study)
- Current blood pressure or other heart medication, including aliskiren and beta blockers)
- Diagnosis of intravascular fluid depletion or dehydration
- History of angioedema
Show all 12Show fewer
- 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)
- Lifetime history of epilepsy or other neurological disorder, as established by a professional diagnosis (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 (as determined by a urine test, if the participant's pregnancy status is unknown during the in-person visit), breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Single-dose Losartan on Social Processing in Healthy Adults: a Randomized Controlled Study
This study explores the effects of single-dose losartan (50mg) versus placebo on social processing in healthy volunteers.
Read the detailed description
While renin-angiotensin mechanisms have been implicated in physiological disease, such as hypertension and stroke, the discovery of a local brain renin-angiotensin system (RAS) in the 1970s brought into question whether the RAS may play a role in psychiatric disorders too. Recent work has supported this link, with several studies reporting RAS influence on aversive learning, stress response to traumatic stimuli, and fear extinction.
Despite these promising results, studies have yet to fully explore the influence of the RAS and losartan on social processes. It is plausible that the RAS may be involved in social functioning, as recent work reported that losartan reduces sensitivity to social punishment in healthy volunteers. Such an effect of losartan may have broad relevance for psychopathology, as impairment to social functioning is present across a range of psychiatric disorders.
In this double-blind, randomized between-group study, the investigators will examine the effects of a single dose of losartan (50mg) versus placebo on social processing in N=68 healthy volunteers. Following a one-hour waiting period, participants will complete a set of computer tasks investigating social processes reported to be sensitive to psychopathology. Specifically, participants will complete the Approach Avoidance Task which assesses social approach and avoidance behaviour in response to various facial expressions via joystick movement, the Interpretation Inflexibility Task which evaluates cognitive flexibility in a social context, the Social Learning Trust Game which evaluates social learning through a trust game between participant investors and realistic trustees, and Cyberball, which probes response to social rejection. Results from this study will provide more insight on the potential role of the RAS in social cognitive processing in humans, which could lead to an improved mechanistic understanding of emotional disorders that are marked by social impairment.
- Conditions
- Social Cognition
- Being tested
- Losartan potassium 50mg, Placebo
- Keywords
- Social Processing, Losartan, Renin Angiotensin System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan potassium 50mgDrug
Also called Losartan, Cozaar
Single dose losartan (50 mg), encapsulated identically to placebo.
PlaceboOther
Single tablet encapsulated identically to placebo.
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | 50 mg single-dose losartan 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.
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: 1 hour after capsule intake
Secondary outcomes (3)
Sensitivity to Social Rejection
- feelings of belonging, control, self-esteem, meaningful existence (on a scale from 1 to 5, with some items reverse coded) as measured on the reflexive and reflective needs-threat scale following Cyberball.
Measured: 1 hour after capsule intake
Social Learning
Social learning rate (early round versus late round investment decisions by generosity condition)
Measured: 1 hour after capsule intake
Interpretation Inflexibility
Within-person revision of biased interpretations: calculated by taking the average of differences between bias scores between stage 3/2 and 2/1. These two differences will be squared before averaging to reflect absolute change (i.e., in either direction), then the square root of the resulting average will be taken. Higher values mean more flexibility in revising prior interpretations.
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 posted3 Oct 2024
- Study start19 Aug 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
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 Social CognitionStudies 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
- 68 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624904
- Sponsor's protocol ID
- R92661
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Prasad D, Pelster I, Outes L, Gillespie A, Pizzagalli DA, Rinck M, Reinecke A. Acute effects of AT1 receptor blockade on approach-avoidance of negative emotional faces. Neuropsychopharmacology. 2026 Sep 15. doi: 10.1038/s41386-026-02554-4. Online ahead of print.
PubMed 42745010
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Single-dose Losartan on Social Processing in Healthy Adults: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06624904
- Acronym / sponsor ID
- R92661
- Conditions
- Social Cognition
- Keywords
- Social Processing, Losartan, Renin Angiotensin System
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 3 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 social processing in healthy volunteers.
Detailed description
While renin-angiotensin mechanisms have been implicated in physiological disease, such as hypertension and stroke, the discovery of a local brain renin-angiotensin system (RAS) in the 1970s brought into question whether the RAS may play a role in psychiatric disorders too. Recent work has supported this link, with several studies reporting RAS influence on aversive learning, stress response to traumatic stimuli, and fear extinction.
Despite these promising results, studies have yet to fully explore the influence of the RAS and losartan on social processes. It is plausible that the RAS may be involved in social functioning, as recent work reported that losartan reduces sensitivity to social punishment in healthy volunteers. Such an effect of losartan may have broad relevance for psychopathology, as impairment to social functioning is present across a range of psychiatric disorders.
In this double-blind, randomized between-group study, the investigators will examine the effects of a single dose of losartan (50mg) versus placebo on social processing in N=68 healthy volunteers. Following a one-hour waiting period, participants will complete a set of computer tasks investigating social processes reported to be sensitive to psychopathology. Specifically, participants will complete the Approach Avoidance Task which assesses social approach and avoidance behaviour in response to various facial expressions via joystick movement, the Interpretation Inflexibility Task which evaluates cognitive flexibility in a social context, the Social Learning Trust Game which evaluates social learning through a trust game between participant investors and realistic trustees, and Cyberball, which probes response to social rejection. Results from this study will provide more insight on the potential role of the RAS in social cognitive processing in humans, which could lead to an improved mechanistic understanding of emotional disorders that are marked by social impairment.
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 50mg50 mg single-dose 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
- Aged 18-50 years
- 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, if vaping: less than 50 puffs)
- BMI between 18 - 30
Key exclusion criteria (12 listed)
- Current DSM-5 axis-I diagnosis (based on SCID results at screening) or history of a severe psychological disorder such as psychotic disorder, bipolar disorder, alcohol or substance abuse, or post-traumatic stress disorder
- First-degree family member with severe psychiatric illness (including psychosis, bipolar disorder, unipolar psychotic depression).
- CNS-medication last 6 weeks (including as part of another study)
- Current blood pressure or other heart medication, including aliskiren and 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 50mgAlso: Losartan, CozaarSingle dose losartan (50 mg), encapsulated identically to placebo. | Drug | Losartan |
| PlaceboSingle tablet encapsulated identically to placebo. | Other | Placebo |
Primary outcome
AAT effect score
Time frame: 1 hour after capsule intake
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
3 secondary outcomes
Sensitivity to Social Rejection
Time frame: 1 hour after capsule intake
Social Learning
Time frame: 1 hour after capsule intake
Interpretation Inflexibility
Time frame: 1 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 24 Sep 2026.
- Derived from this study: PubMed 42745010Prasad D, Pelster I, Outes L, Gillespie A, Pizzagalli DA, Rinck M, Reinecke A. Acute effects of AT1 receptor blockade on approach-avoidance of negative emotional faces. Neuropsychopharmacology. 2026 Sep 15. doi: 10.1038/s41386-026-02554-4. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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None Volunteer
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 Early Phase 1 study testing Losartan potassium 50mg in people with Social Cognition, 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: finished, as of the sponsor's last update on 24 Sep 2026. 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?
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?
AAT effect score (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 NCT06624904, 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 24 Sep 2026.