HealthyNCT04604938
The Effects of Losartan on Reward Reinforcement Learning
A study testing Losartan in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
This study aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related neural mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2020to 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
- Normal or corrected-normal version
Who cannot join
- History of head injury
- Medical or psychiatric illness
- Hypertension
- General cardio-vascular alteration or diseases
- Allergy against medications
- Visual or motor impairments
Show all 10Show fewer
- Claustrophobia
- Drug addiction
- Nicotine dependence
- FMRI contradictions
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
Weihua Zhao, PhD, zarazhao.uestc@outlook.com
About this study
Official title: The Role of the Renin-angiotensin System in Reward Reinforcement Learning
This study aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related neural mechanisms.
Read the detailed description
Emerging evidence suggests that the renin-angiotensin system can impact dopamine (DA) transmission and its modulatory role in reward processing. For instance, recent animal models have found that the angiotensin antagonist losartan reduces rewarding effects of methamphetamine and nicotine by modulating DA release in the striatum.The present study thus will investigate losartan effects on reward reinforcement learning and the underlying neural mechanisms. In a double-blind, between-subject, placebo-controlled design, 60 healthy male subjects will be randomly assigned to receive single-dose losartan (50 mg) or placebo, 90 minutes before performing a probabilistic reinforcement learning task during fMRI.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar Oral Tablet
administration of losartan (50 mg) (oral)
Placebo oral tabletDrug
administration of placebo (oral)
| Study group | Role | What they receive |
|---|---|---|
| Losartan group | Experimental | Drug: Losartan Receives: Drug: Losartan |
| Placebo group | Placebo comparator | Drug: Placebo Oral Tablet Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD-level activity as assessed by fMRI during the learning phase
During the paradigm subjects will learn the reward properties of stimuli via the presentation of trial-wise feedback. The neural activation during the prediction of positive and negative outcome feedback will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions. The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.
Measured: 90 minutes to 110 minutes after treatment
BOLD-level activity as assessed by fMRI during the learning transfer phase
Following the initial learning phase subjects learning transfer will be examined by asking subjects to choose between stimuli with high versus low reward probabilities. The neural activation during correct responses will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions. The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.
Measured: 111 minutes to 120 minutes after treatment
Secondary outcomes (3)
Choice accuracy for the stimulus with the high reward probability during the learning phase
During the learning phase accuracies (in percent) for choosing the stimulus with the highest reward probability will be computed. Effects of treatment on choice accuracy in the probabilistic learning task will be examined by comparing accuracies (percent) between the losartan- and placebo-treated group.
Measured: 90 minutes to 110 minutes after treatment
Learning rate for positive and negative outcomes
The learning rate will be determined by performing computational modelling. The learning rate index for positive and negative outcomes during the learning phase will be compared between the losartan- and placebo-treated group.
Measured: 90 minutes to 110 minutes after treatment
Choice accuracy during the learning transfer phase
Following the initial learning phase subjects learning transfer will be examined by asking subjects to choose between stimuli with high versus low reward probabilities. For the transfer phase the choice accuracy for selecting stimuli with the highest reward probability and avoiding stimuli with the lowest reward probability will be computed. The effects of treatment will be determined by comparing the accuracy between the losartan- and placebo-treated groups.
Measured: 111 minutes to 120 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start10 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
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 HealthyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Becker, University of Electronic Science and Technology of China
- Investigators
- Benjamin Becker, PhD, Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604938
- Sponsor's protocol ID
- UESTC-neuSCAN-75
- Status last verified
- Oct 2020
- First submitted
- 9 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu T, Zhou X, Kanen JW, Wang L, Li J, Chen Z, Zhang R, Jiao G, Zhou F, Zhao W, Yao S, Becker B. Angiotensin blockade enhances motivational reward learning via enhancing striatal prediction error signaling and frontostriatal communication. Mol Psychiatry. 2023 Apr;28(4):1692-1702. doi: 10.1038/s41380-023-02001-6. Epub 2023 Feb 21.
PubMed 36810437
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Renin-angiotensin System in Reward Reinforcement Learning
- ClinicalTrials.gov ID
- NCT04604938
- Acronym / sponsor ID
- UESTC-neuSCAN-75
- Conditions
- Healthy
- Keywords
- Losartan, Reward reinforcement learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 27 Oct 2020 (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 aims to investigate whether a single dose of losartan (50 mg) can affect learning from positive and negative outcomes and its related neural mechanisms.
Detailed description
Emerging evidence suggests that the renin-angiotensin system can impact dopamine (DA) transmission and its modulatory role in reward processing. For instance, recent animal models have found that the angiotensin antagonist losartan reduces rewarding effects of methamphetamine and nicotine by modulating DA release in the striatum.The present study thus will investigate losartan effects on reward reinforcement learning and the underlying neural mechanisms. In a double-blind, between-subject, placebo-controlled design, 60 healthy male subjects will be randomly assigned to receive single-dose losartan (50 mg) or placebo, 90 minutes before performing a probabilistic reinforcement learning task during fMRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan group | Experimental | Drug: LosartanDrug: Losartan |
| Placebo group | Placebo comparator | Drug: Placebo oral tabletDrug: Placebo Oral Tablet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
- Normal or corrected-normal version
Key exclusion criteria (10 listed)
- History of head injury
- Medical or psychiatric illness
- Hypertension
- General cardio-vascular alteration or diseases
- Allergy against medications
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: Cozaar Oral Tabletadministration of losartan (50 mg) (oral) | Drug | Losartan group |
| Placebo oral tabletadministration of placebo (oral) | Drug | Placebo group |
Primary outcome
BOLD-level activity as assessed by fMRI during the learning phase
Time frame: 90 minutes to 110 minutes after treatment
During the paradigm subjects will learn the reward properties of stimuli via the presentation of trial-wise feedback. The neural activation during the prediction of positive and negative outcome feedback will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions. The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.
BOLD-level activity as assessed by fMRI during the learning transfer phase
Time frame: 111 minutes to 120 minutes after treatment
Following the initial learning phase subjects learning transfer will be examined by asking subjects to choose between stimuli with high versus low reward probabilities. The neural activation during correct responses will be assessed by functional magnetic resonance imaging (fMRI), particularly in prefrontal and subcortical regions. The effects of treatment will be determined by comparing the losartan- and placebo-treated groups.
3 secondary outcomes
Choice accuracy for the stimulus with the high reward probability during the learning phase
Time frame: 90 minutes to 110 minutes after treatment
Learning rate for positive and negative outcomes
Time frame: 90 minutes to 110 minutes after treatment
Choice accuracy during the learning transfer phase
Time frame: 111 minutes to 120 minutes after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Derived from this study: PubMed 36810437Xu T, Zhou X, Kanen JW, Wang L, Li J, Chen Z, Zhang R, Jiao G, Zhou F, Zhao W, Yao S, Becker B. Angiotensin blockade enhances motivational reward learning via enhancing striatal prediction error signaling and frontostriatal communication. Mol Psychiatry. 2023 Apr;28(4):1692-1702. doi: 10.1038/s41380-023-02001-6. Epub 2023 Feb 21.
- Individual participant dataSharing planned: No
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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.
Benjamin Becker, PhD principal investigator
University of Electronic Science and Technology of China
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 in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
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 3 inclusion and 10 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 27 Oct 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weihua Zhao, PhD (86-28-61830811, zarazhao.uestc@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD-level activity as assessed by fMRI during the learning phase (time frame: 90 minutes to 110 minutes after treatment). The study lists 2 primary outcomes in all. 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 NCT04604938, 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 27 Oct 2020.