Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT00753051
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2008-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT)
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': 'D006220', 'term': 'Haloperidol'}, {'id': 'D003024', 'term': 'Clozapine'}, {'id': 'D004565', 'term': 'Electroconvulsive Therapy'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PANSS , HAM-D , CGI , AIMS Scores', 'timeFrame': 'every 4 weeks for 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['clozapine-resistant schizophrenics', 'haloperidol augmenting clozapine', 'electroconvulsive therapy augmenting clozapine'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'Clozapine treatment resistant schizophrenia is still prevalent.The effectiveness of augmenting clozapine : one augmenting with haloperidol and the other with electroconvulsive therapy should be determined.This study is a randomized control trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. schizophrenic patients diagnosed with schedules for clinical assessment in neuropsychiatry ( SCAN )in accordance with DSM-IV-TR or ICD-10\n2. Resistant to at least 6 weeks of clozapine treatment in therapeutic dosage\n3. Voluntary to participate the research protocol expressed by signing informed consent form\n\nExclusion Criteria:\n\n1. Patient does not volunteer himself or herself\n2. Patient is having epilepsy, DM, cardiac disease, autistic disorder and illiterate\n3. Patient is deaf, blind , dumb to obstruct good communication'}, 'identificationModule': {'nctId': 'NCT00753051', 'acronym': 'TCRS', 'briefTitle': 'Treat Clozapine ( CLZ )-Resistant Schizophrenia Comparing CLZ + Haloperidol vs. CLZ + Electroconvulsive Therapy (ECT)', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Treatment of Clozapine-resistant Schizophrenia : Comparison Between Augmentation With Haloperidol and Electroconvulsive Therapy', 'orgStudyIdInfo': {'id': 'HE501122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1.', 'description': 'clozapine as the main agent and it will be adjuncted by haloperidol', 'interventionNames': ['Drug: clozapine+haloperidol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2.', 'description': 'clozapine as the main agent and it will be adjuncted by electroconvulsive therapy', 'interventionNames': ['Drug: clozapine,electroconvulsive therapy']}], 'interventions': [{'name': 'clozapine+haloperidol', 'type': 'DRUG', 'otherNames': ['clopaze, haloperidol'], 'description': 'clozapine 300-900 mg/d haloperidol 4-60 mg/d', 'armGroupLabels': ['1.']}, {'name': 'clozapine,electroconvulsive therapy', 'type': 'DRUG', 'otherNames': ['clopaze , Thymatron ECT machine'], 'description': 'clozapine 300-900 mg/d electroconvulsive therapy 4-12 times', 'armGroupLabels': ['2.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Muang', 'state': 'KhonKaen', 'country': 'Thailand', 'facility': 'Department of Psychiatry.Faculty of Medicine.KhonKaen University.'}], 'overallOfficials': [{'name': 'Suchat Paholpak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry.Faculty of Medicine.Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Suchat Paholpak', 'investigatorAffiliation': 'Khon Kaen University'}}}}