Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00951418
Status:
COMPLETED
Last Update Posted:
2013-09-12
First Post:
2009-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Clozapine and Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-11', 'studyFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2013-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function measured by CANTAB', 'timeFrame': 'once'}], 'secondaryOutcomes': [{'measure': 'T-wave morphology', 'timeFrame': 'Once'}, {'measure': 'Sedation VAS,ACES and SWAI scale', 'timeFrame': 'once'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clozapine', 'schizophrenia', 'cognition', 't-wave morphology'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated with clozapine for minimum 6 months.\n* Fixed dosage of clozapine last month before inclusion.\n\nExclusion Criteria:\n\n* Substance misuse.\n* Depression (Calgary Depression score ≥7).\n* Somatic disease that interfere with cognitive performance.\n* Treatment with benzodiazepines (half-lives \\>15 hours not allowed up 14 days prior inclusion and during study. Half-lives \\< 15 hours not allowed 3 days prior cognitive testing).\n* Electroconvulsive therapy.\n* Treatment with other antipsychotics.\n* Withdrawal of informed consent.\n* Compulsory measures.\n* Treatment with anticholinergics except for atropine drops administered sublingually.\n* Changes in use of tobacco last month before inclusion.'}, 'identificationModule': {'nctId': 'NCT00951418', 'briefTitle': 'Serum Clozapine and Cognition', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Serum Clozapine and Cognition', 'orgStudyIdInfo': {'id': '1.5-15 July 2008'}}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Psychiatric Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Rene Ernst Nielsen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg Psychiatric Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}