Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 6:29 AM
Study NCT ID:
NCT04604756
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2020-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Losartan on Social Reward
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': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-10-09', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the anticipation of social feedback.', 'timeFrame': '90 minutes to 105 minutes after treatment', 'description': 'The social incentive delay task provides subjects with trial-wise feedback on their performance (as assessed by reaction time). Neural activity will be measured by functional magnetic resonance imaging (fMRI). To examine effects of treatment during the anticipation of social feedback fMRI-based neural indices during the anticipation period will be compared between the losartan and the placebo treated group using a Generalized Linear Model approach. The analysis will focus on brain systems that play an important role in the anticipation of reward and punishment (prefrontal cortex and subcortical regions, including the striatum)'}, {'measure': 'Losartan effects on neural activity as assessed by blood oxygenation dependent (BOLD) fMRI during the consummation of social feedback.', 'timeFrame': '90 minutes to 105 minutes after treatment', 'description': 'The social incentive delay task provides subjects with trial-wise feedback on their performance (as assessed by reaction time). Following each trial the feedback will be indicated by positive and negative social stimuli. Neural activity will be measured by functional magnetic resonance imaging (fMRI). To examine effects of treatment during the consummation of social feedback fMRI-based neural indices during the presentation of the feedback will be compared between the losartan and the placebo treated group using a Generalized Linear Model approach. The analysis will focus on brain systems that play an important role in reward and punishment (prefrontal cortex and subcortical regions, including the striatum)'}], 'secondaryOutcomes': [{'measure': 'Effects of Losartan on arousal ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales', 'timeFrame': '150 minutes to 160 minutes after treatment', 'description': 'Following the fMRI assessment participants will be asked to rate the arousal of the stimuli presented during fMRI. Arousal will be assessed on 1-9 Likert rating scales. To examine effects of treatment on arousal ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.'}, {'measure': 'Effects of Losartan on valence ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales', 'timeFrame': '150 minutes to 160 minutes after treatment', 'description': 'Following the fMRI assessment participants will be asked to rate the valence of the stimuli presented during fMRI. Valence will be assessed on 1-9 Likert rating scales. To examine effects of treatment on valence ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.'}, {'measure': 'Effects of Losartan on intensity ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales', 'timeFrame': '150 minutes to 160 minutes after treatment', 'description': 'Following the fMRI assessment participants will be asked to rate the intensity of the stimuli presented during fMRI. Intensity will be assessed on 1-9 Likert rating scales. To examine effects of treatment on intensity ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.'}, {'measure': 'Effects of Losartan on likeability ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales', 'timeFrame': '150 minutes to 160 minutes after treatment', 'description': 'Following the fMRI assessment participants will be asked to rate the likeability of the stimuli presented during fMRI. Likeability will be assessed on 1-9 Likert rating scales. To examine effects of treatment on likeability ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.'}, {'measure': 'Effects of Losartan on dislikeability ratings of the stimuli presented during the fMRI-paradigm as assessed by 1-9 Likert scales', 'timeFrame': '150 minutes to 160 minutes after treatment', 'description': 'Following the fMRI assessment participants will be asked to rate the dislikeability of the stimuli presented during fMRI. Dislikeability will be assessed on 1-9 Likert rating scales. To examine effects of treatment on dislikeability ratings the losartan and placebo groups will be compared using Generalized Linear Model approach.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Losartan', 'Social reward'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of losartan (50mg, single dose) on social reward', 'detailedDescription': 'In a double-blind, between-subject, placebo-controlled design the effects of a single dose of losartan (50mg) on social reward in healthy participants will be examined. 90 minutes after subjects administrate 50mg losartan or placebo, participants will undergo a social incentive delay task. Neural activity will be assessed by the acquisition of functional magnetic resonance imaging (fMRI) data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects without past or current psychiatric or neurological disorders\n\nExclusion Criteria:\n\n* history of head injury\n* medical or psychiatric illness\n* hypertension'}, 'identificationModule': {'nctId': 'NCT04604756', 'briefTitle': 'The Effects of Losartan on Social Reward', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'Losartan Effects on the Social Reward in Humans', 'orgStudyIdInfo': {'id': 'UESTC-neuSCAN-72'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Losartan group', 'description': 'Drug: Losartan', 'interventionNames': ['Drug: Losartan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Drug: Placebo Oral Tablet', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['Cozaar Oral Tablet'], 'description': 'administration of losartan (50 mg) (oral)', 'armGroupLabels': ['Losartan group']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'administration of placebo (oral)', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weihua Zhao, PhD', 'role': 'CONTACT', 'email': 'zarazhao.uestc@outlook.com'}], 'facility': 'University of Electronic Science and Technology of China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Weihua Zhao, PhD', 'role': 'CONTACT', 'email': 'zarazhao.uestc@outlook.com', 'phone': '86-28-61830811'}], 'overallOfficials': [{'name': 'Benjamin Becker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Electronic Science and Technology of China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}