Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-28 @ 7:56 PM
Study NCT ID:
NCT02625103
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D003024', 'term': 'Clozapine'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2015-12-06', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in serum-clozapine', 'timeFrame': '10 - 14 hours post drug administration'}], 'secondaryOutcomes': [{'measure': 'Percentage change in serum-clozapine (multiple shorter ranges)', 'timeFrame': '< 10 -14 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia, Clozapine, TDM, Serum Concentration'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring should be drawn 12 hours post dose.\n\nThe scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .', 'detailedDescription': 'Several factors can influence s-clozapine and thereby the occurence of dose-related adverse reactions and level of treatment response. The role of Therapeutic Drug Monitoring (TDM) in clozapine dose adjustment have been debated. Blood samples for s-clozapine monitoring are recommended to be drawn 12 hours post dose. Uncertainty regarding the timing of blood sampling and the individual pharmakokinetics for clozapine +/- 2 hours from the 12-hour timepoint, leads to uncertainty regarding the comparability of serum concentrations and the information hold within them.\n\nThe scope of this trial is to describe changes of s-clozapine and s-N-desmethyl-clozapine within the range of 10-14 hours after the last administration of clozapine .\n\nIn addition we want to investigate if any of the following covariates might affect the change of s-clozapine and s-N-desmethyl-clozapine: Sex, age, BMI, co-medications, signs of infection, caffeine intake and smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 \\< 65\n* Diagnosed with schizophrenia according to the criteria of ICD10 (International Classification of Diseases, World Health Organization) or the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, the American Psychiatric Association)\n* Unchanged dose of clozapine for the last 30 days\n* Usual time of clozapine evening-dose administration between 9 and 12 pm.\n\nExclusion Criteria:\n\n* Significant drug or alcohol abuse that affects participation in this trial\n* Non- or partial compliance of clozapine the day before the trial (assessed by interview)\n* Unresponsive by telephone the evening before the trial\n* Consumption of clozapine in the morning on the day of the trial\n* Significant change in smoking habits within the last 30 days (assessed by interview)\n* Significant change of caffeine intake within the last 7 days (assessed by interview)\n* Modified use of other antipsychotics within the last 30 days\n* Within the last 30 days (7 days for hormone based contraceptives) changes in the use of other medications that can affect s- clozapine during the trial : ( fluvoxamine, ciprofloxacin, hormone based contraceptives, carbamazepine , phenytoin , rifampicin, omeprazole )\n* Females who are pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT02625103', 'briefTitle': 'The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring.', 'organization': {'class': 'OTHER', 'fullName': 'Psychiatric Centre Rigshospitalet'}, 'officialTitle': 'The Significance of Deviation in Time From the 12-hour Standard Serum-clozapine Monitoring', 'orgStudyIdInfo': {'id': 'CLO-MEAS'}, 'secondaryIdInfos': [{'id': '2015-002520-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clozapine', 'description': 'treatment as usual: administration of clozapine between 9 and 12 pm. Blood sampling 10 -14 hours post drug administration', 'interventionNames': ['Procedure: Blood sampling', 'Drug: Clozapine']}], 'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration', 'armGroupLabels': ['Clozapine']}, {'name': 'Clozapine', 'type': 'DRUG', 'otherNames': ['Leponex'], 'description': 'Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.', 'armGroupLabels': ['Clozapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'København Ø', 'country': 'Denmark', 'facility': 'Psychiatric Centre Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Anders Fink-Jensen, MD, DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatric Centre Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anders Fink-Jensen, MD, DMSci', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, DMSci', 'investigatorFullName': 'Anders Fink-Jensen, MD, DMSci', 'investigatorAffiliation': 'Psychiatric Centre Rigshospitalet'}}}}