Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-24 @ 3:03 PM
Study NCT ID:
NCT06329050
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Losartan on Attention Control: An Eye-tracking Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Saccade/antisaccade latency difference between social and non-social stimuli after losartan administration', 'timeFrame': '90 minutes - 120 minutes after treatment', 'description': 'Comparison between social-specific saccade/antisaccade latencies (in milliseconds) between the losartan and placebo treatment conditions.'}, {'measure': 'Error rate of saccade/antisaccade for social versus non-social stimuli after losartan administration', 'timeFrame': '90 minutes - 120minutes after treatment', 'description': 'Comparison between social-specific error rates of saccade/antisaccade between the losartan and placebo treatment conditions.'}], 'secondaryOutcomes': [{'measure': 'Saccade/antisaccade latency for different facial emotions after losartan administration', 'timeFrame': '90 minutes - 120 minutes after treatment', 'description': 'Comparison between emotion-specific saccade/antisaccade latencies (in milliseconds) between the losartan and placebo treatment conditions.'}, {'measure': 'Error rate of saccade/antisaccade for different facial emotions after losartan administration', 'timeFrame': '90 minutes - 120 minutes after treatment', 'description': 'Comparison between emotion-specific saccade/antisaccade error rates between the losartan and placebo treatment conditions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eye-tracking', 'Losartan'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent.\n\nNormal or corrected-normal version\n\nExclusion Criteria:\n\n* History of neuropsychiatric diseases.\n* History of cardiac disease, including arrhythmias, aortic stenosis, or congestive heart failure; history of syncope or unexplained loss of consciousness.\n* History of hepatic diseases, including cholestasis, biliary obstructive disease, or severe liver dysfunction.\n* History of renal diseases, including renal stones or renal failure.\n* History of hyponatremia(Serum sodium \\<135mmol/L) or hyperkalemia (Serum potassium\\>5.5mmol/L); history of diabetes mellitus or diabetes insipidus\n* Known hypersensitivity or allergic reaction to any medication or hormone; strong allergic reaction to food.\n* Infections such as COVID-19 or influenza, or unexplained fever.\n* Subjects with hypertension (BP ≥130/80mmHg) or hypotension (BP ≤ 90/60mmHg).\n* History of alcohol or drug abuse; smoker (≥ 10 cigarettes or ≥ 3 cigars or ≥ 3 pipes/day); smoker using e-cigarettes.\n* Blood donation (≤ 1 month prior to administration).\n* Take oral contraceptives or receive hormonal medications in the three months prior to the experiment.\n* Pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06329050', 'briefTitle': 'The Effects of Losartan on Attention Control: An Eye-tracking Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'The Effects of Losartan on Attention Control: An Eye-tracking Study', 'orgStudyIdInfo': {'id': 'BAM_lab_eyetracking_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Losartan group', 'description': 'Losartan tablet(50 mg)', 'interventionNames': ['Drug: Losartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['Cozaar'], 'description': 'Administration of Losartan tablets(50 mg)', 'armGroupLabels': ['Losartan group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo treatment'], 'description': 'Administration of Placebo tablets', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihua Zhao, Dr', 'role': 'CONTACT', 'email': 'zarazhao.uestc@outlook.com', 'phone': '86-28-61830811'}], 'facility': 'University of Electronic Science and Technology of China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Weihua Zhao, Dr', 'role': 'CONTACT', 'email': 'zarazhao.uestc@outlook.com', 'phone': '86-28-61830811'}], 'overallOfficials': [{'name': 'Benjamin Becker, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Electronic Science and Technology of China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Electronic Science and Technology of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Benjamin Becker', 'investigatorAffiliation': 'University of Electronic Science and Technology of China'}}}}