- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06329050
The Effects of Losartan on Attention Control: An Eye-tracking Study
April 9, 2024 updated by: Benjamin Becker, University of Electronic Science and Technology of China
The main aim of the present study is to investigate the effects of orally administered Losartan on bottom-up and top-down attentional control to socio-emotional stimuli by combining a validated saccade/antisaccade eye-tracking paradigm with a randomized between-subject placebo-controlled pharmacological trial design.
Study Overview
Detailed Description
Animal models and initial findings in humans suggest that the angiotensin II antagonist Losartan may have neuroprotective effects and could potentially enhance cognitive functions, including valence-specific attention and regulatory control.
Within this context the present study aims to examine whether angiotensin II blockade via Losartan modulates top-down and bottom-up attentional control towards socio-affective stimuli.
To this end, healthy individuals will undergo a double-blind, between-subjects, placebo-controlled pharmaco-eye-tracking experiment and receive a single oral dose of Losartan (50 mg) or placebo before performing a saccade/anti-saccade task 90 minutes after administration.
The task paradigm will encompass social (happy, angry, fearful, sad and neutral faces) and non-social (oval) stimuli to examine general as well as social and emotion-specific effects of oral losartan.
Study Type
Interventional
Enrollment (Estimated)
80
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 Contact
- Name: Weihua Zhao, Dr
- Phone Number: 86-28-61830811
- Email: zarazhao.uestc@outlook.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 611731
- Recruiting
- University of Electronic Science and Technology of China
-
Contact:
- Weihua Zhao, Dr
- Phone Number: 86-28-61830811
- 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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Healthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.
Normal or corrected-normal version
Exclusion Criteria:
- History of neuropsychiatric diseases.
- History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.
- History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.
- History of renal diseases, including renal stones or renal failure.
- History of hyponatremia(Serum sodium <135mmol/L) or hyperkalemia (Serum potassium>5.5mmol/L); history of diabetes mellitus or diabetes insipidus
- Known hypersensitivity or allergic reaction to any medication or hormone; strong allergic reaction to food.
- Infections such as COVID-19 or influenza, or unexplained fever.
- Subjects with hypertension (BP ≥130/80mmHg) or hypotension (BP ≤ 90/60mmHg).
- History of alcohol or drug abuse; smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day); smoker using e-cigarettes.
- Blood donation (≤ 1 month prior to administration).
- Take oral contraceptives or receive hormonal medications in the three months prior to the experiment.
- Pregnant or breastfeeding.
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
Losartan tablet(50 mg)
|
Administration of Losartan tablets(50 mg)
Other Names:
|
Placebo Comparator: Placebo group
Placebo tablet
|
Administration of Placebo tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saccade/antisaccade latency difference between social and non-social stimuli after losartan administration
Time Frame: 90 minutes - 120 minutes after treatment
|
Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the losartan and placebo treatment conditions.
|
90 minutes - 120 minutes after treatment
|
Error rate of saccade/antisaccade for social versus non-social stimuli after losartan administration
Time Frame: 90 minutes - 120minutes after treatment
|
Comparison between social-specific error rates of saccade/antisaccade between the losartan and placebo treatment conditions.
|
90 minutes - 120minutes after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saccade/antisaccade latency for different facial emotions after losartan administration
Time Frame: 90 minutes - 120 minutes after treatment
|
Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the losartan and placebo treatment conditions.
|
90 minutes - 120 minutes after treatment
|
Error rate of saccade/antisaccade for different facial emotions after losartan administration
Time Frame: 90 minutes - 120 minutes after treatment
|
Comparison between emotion-specific saccade/antisaccade error rates between the losartan and placebo treatment conditions.
|
90 minutes - 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, Dr, 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)
March 5, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
July 30, 2025
Study Registration Dates
First Submitted
March 15, 2024
First Submitted That Met QC Criteria
March 15, 2024
First Posted (Actual)
March 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAM_lab_eyetracking_02
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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