Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-01 @ 1:30 PM
Study NCT ID:
NCT00846950
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2009-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of H1-Antagonist on Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C018904', 'term': 'dexchlorpheniramine'}, {'id': 'D008140', 'term': 'Lorazepam'}], 'ancestors': [{'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-18', 'studyFirstSubmitDate': '2009-02-17', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P300 latency and LRP onset latency', 'timeFrame': '1.5 hours after treatment'}], 'secondaryOutcomes': [{'measure': 'Words recalled', 'timeFrame': '1.5 hours after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['H1-antagonist', 'Event Related Potentials', 'Memory', 'Information processing', 'The effects of an H1 antagonist (dexchlorpheniramine) on human cognition'], 'conditions': ['Cognition']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether histamine is involved in memory and specific processes in human cognition.', 'detailedDescription': 'The neurotransmitter histamine appears to be involved in human cognitive performance. However, the exact role is very unclear. The role it plays in memory performance is highly disputed, as animal studies show decreased performance when the H1-receptor is blocked in the central nervous system while such findings in humans is scarce. To clarify the role of histamine in human memory and different processes in cognition, the effects of an H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are measured. The study will be conducted according to a within subject cross-over design using healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by a physician\n\nExclusion Criteria:\n\n* present or history of any neurological of psychiatric disease\n* present or history of any substance abuse'}, 'identificationModule': {'nctId': 'NCT00846950', 'briefTitle': 'Effects of H1-Antagonist on Cognition', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Effects of H1-Antagonist on Stages of Human Information Processing', 'orgStudyIdInfo': {'id': '06-3-075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'healthy volunteers', 'interventionNames': ['Drug: dexchlorpheniramine, lorazepam']}], 'interventions': [{'name': 'dexchlorpheniramine, lorazepam', 'type': 'DRUG', 'armGroupLabels': ['healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 ER', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Faculty of Psychology and Neuroscience, Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Annemiek Vermeeren, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Effects of H1-antagonist on stages of human information processing', 'oldOrganization': 'Dr. A. Vermeeren'}}}}