- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04604938
The Effects of Losartan on Reward Reinforcement Learning
October 21, 2020 updated by: Benjamin Becker, University of Electronic Science and Technology of China
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- University of Electronic Science and Technology of China
-
Contact:
- Weihua Zhao, PhD
- Email: zarazhao.uestc@outlook.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy subjects without past or current psychiatric or neurological disorders
- Right-handedness
- Normal or corrected-normal version
Exclusion Criteria:
- History of head injury
- Medical or psychiatric illness
- Hypertension
- General cardio-vascular alteration or diseases
- Allergy against medications
- Visual or motor impairments
- Claustrophobia
- Drug addiction
- Nicotine dependence
- FMRI contradictions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Losartan group
Drug: Losartan
|
administration of losartan (50 mg) (oral)
Other Names:
|
Placebo Comparator: Placebo group
Drug: Placebo Oral Tablet
|
administration of placebo (oral)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
90 minutes to 110 minutes after treatment
|
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.
|
111 minutes to 120 minutes after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Choice accuracy for the stimulus with the high reward probability during the learning phase
Time Frame: 90 minutes to 110 minutes after treatment
|
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.
|
90 minutes to 110 minutes after treatment
|
Learning rate for positive and negative outcomes
Time Frame: 90 minutes to 110 minutes after treatment
|
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.
|
90 minutes to 110 minutes after treatment
|
Choice accuracy 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.
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.
|
111 minutes to 120 minutes after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin Becker, PhD, University of Electronic Science and Technology of China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2020
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
March 31, 2022
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (Actual)
October 27, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 21, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-75
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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