Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01138618
Status:
COMPLETED
Last Update Posted:
2011-11-07
First Post:
2010-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)
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': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-04', 'studyFirstSubmitDate': '2010-05-21', 'studyFirstSubmitQcDate': '2010-06-04', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain sensation', 'timeFrame': 'Monthly for four months', 'description': 'Pain sensation was measured using a visual analog scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'The benefits of CHEMPAQ', 'timeFrame': 'Monthly for four months', 'description': 'Caregivers and patients were asked about the benefits of using CHEMPAQ for hematological clozapine monitoring.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clozapine', 'hematological monitoring', 'CHEMPAQ', 'Granulocytes', 'WBC'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '3046553', 'type': 'BACKGROUND', 'citation': 'Kane J, Honigfeld G, Singer J, Meltzer H. Clozapine for the treatment-resistant schizophrenic. A double-blind comparison with chlorpromazine. Arch Gen Psychiatry. 1988 Sep;45(9):789-96. doi: 10.1001/archpsyc.1988.01800330013001.'}]}, 'descriptionModule': {'briefSummary': 'Clozapine remain the drug of choice for treatment resistant schizophrenia and up to 60% of patients not responding to other antipsychotics will respond to clozapine. However, the use of clozapine is restricted due to the risk of agranulocytosis and consequently the need for mandatory hematological monitoring. CHEMPAQ XBC is a point-of-care device that can be used in patients home and analyze WBC and granulocytes by a single capillary blood drop. This study aims to investigate whether this new procedure increases the acceptability of clozapine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with clozapine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treated with clozapine\n* Compliant with blood monitoring\n* Willing to give informed consent\n\nExclusion Criteria:\n\n* Prior case of agranulocytosis'}, 'identificationModule': {'nctId': 'NCT01138618', 'acronym': 'CHEMPAQ', 'briefTitle': 'Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Hematological Clozapine Monitoring With a Point-of-care Device (CHEMPAQ)', 'orgStudyIdInfo': {'id': '1.5 - 01 MARCH2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CHEMPAQ-venous-CHEMPAQ-venous', 'description': 'The two arms only differ in order of kind of blood samples.', 'interventionNames': ['Device: Venous blod sample', 'Device: CHEMPAQ']}, {'label': 'Venous-CHEMPAQ-Venous-CHEMPAQ', 'description': 'The two arms only differ in order of kind of blood samples.', 'interventionNames': ['Device: Venous blod sample', 'Device: CHEMPAQ']}], 'interventions': [{'name': 'Venous blod sample', 'type': 'DEVICE', 'description': 'Regular venous blood sample withdrawn from the laboratory', 'armGroupLabels': ['CHEMPAQ-venous-CHEMPAQ-venous', 'Venous-CHEMPAQ-Venous-CHEMPAQ']}, {'name': 'CHEMPAQ', 'type': 'DEVICE', 'description': 'Capillary blood sample analyzed by CHEMPAQ', 'armGroupLabels': ['CHEMPAQ-venous-CHEMPAQ-venous', 'Venous-CHEMPAQ-Venous-CHEMPAQ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2670', 'city': 'Greve', 'state': 'Greve', 'country': 'Denmark', 'facility': 'Psychiatric Center Roskilde', 'geoPoint': {'lat': 55.58333, 'lon': 12.3}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Psychiatric Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8240', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Psychiatric Center Aarhus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Psychiatric Center Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Psychiatric Centre Esbjerg', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Psychiatric Center Odense', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jimmi Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg Psychiatric Hospital, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg Psychiatric Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}