Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-30 @ 4:46 PM
Study NCT ID:
NCT00954603
Status:
TERMINATED
Last Update Posted:
2011-06-23
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069348', 'term': 'Quetiapine Fumarate'}, {'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'few delirious patients were enrolled.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-06', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decrease in delirium rating scale and clinical global improvement', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'compare extrapyramidal and other report side effects of quetiapine and haloperidol from modified Simpson Angus scale and other report side effects.', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['delirium rating scale', 'clinical global improvement', 'extrapyramidal side effect'], 'conditions': ['Delirium']}, 'referencesModule': {'references': [{'pmid': '18041437', 'type': 'RESULT', 'citation': 'Maneeton B, Maneeton N, Srisurapanont M. An open-label study of quetiapine for delirium. J Med Assoc Thai. 2007 Oct;90(10):2158-63.'}, {'pmid': '23926422', 'type': 'DERIVED', 'citation': 'Maneeton B, Maneeton N, Srisurapanont M, Chittawatanarat K. Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial. Drug Des Devel Ther. 2013 Jul 24;7:657-67. doi: 10.2147/DDDT.S45575. Print 2013.'}], 'seeAlsoLinks': [{'url': 'http://emedicine.medscape.com/article/288890-treatment', 'label': 'treatment delirium'}, {'url': 'http://www.icudelirium.org/', 'label': 'treatment delirium'}, {'url': 'http://en.wikipedia.org/wiki/Delirium#Treatment', 'label': 'treatment delirium'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether quetiapine, and haloperidol are effective and safe in the treatment psychiatric symptoms in patients with delirium.', 'detailedDescription': 'A delirious state often founds in general hospitals and remains a significant cause of death. Existing methods of treatment includes identification and elimination of factors contributing to the delirium in addition to pharmacological and nonpharmacological treatment interventions (Trzepacz et al., 1999). Antipsychotics can play an important role in the management of the symptoms of delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 18 -75 years\n* Was admitted in Maharaj Nakhon Chiang Mai hospital\n* Was diagnosed by the diagnostic criteria for DSM-IV-TR delirium due to a general medical condition or delirium due to multiple etiologies\n* Delirious state (delirium) of the patients was confirmed by using name-assess confusion assessment method (CAM) and assessment of severity with delirium rating scale-revised-98 (DRS-R-98)\n* Have a written consent from the legal representatives\n\nExclusion Criteria:\n\n* Was diagnosed substance withdrawal delirium\n* Having a history drug allergy either from quetiapine or haloperidol\n* Female patients who are pregnant or breastfeeding\n* No written consent from the legal representatives\n* Received other anti-psychotic drug before attend the study\n* Being ill with renal or hepatic failure'}, 'identificationModule': {'nctId': 'NCT00954603', 'acronym': 'QHdelirium', 'briefTitle': 'A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium', 'orgStudyIdInfo': {'id': 'MedCMU Que vs Halo - 2008'}, 'secondaryIdInfos': [{'id': 'Que vs Halo - 2008', 'type': 'OTHER', 'domain': '077/2552'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'quetiapine', 'description': 'atypical antipsychotic drug', 'interventionNames': ['Drug: quetiapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'haloperidol', 'description': 'typical antipsychotic drug', 'interventionNames': ['Drug: haloperidol']}], 'interventions': [{'name': 'quetiapine', 'type': 'DRUG', 'otherNames': ['seroquel'], 'description': '25-100 mg', 'armGroupLabels': ['quetiapine']}, {'name': 'haloperidol', 'type': 'DRUG', 'otherNames': ['haldol'], 'description': '0.5-2 mg', 'armGroupLabels': ['haloperidol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Department of psychiatry, faculty of medicine, Chiang Mai university', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Benchalak Maneeton, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry,Faculty of Medicine, Chiang Mai university, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Associate prof. Benchalak Maneeton', 'oldOrganization': 'department of psychiatry, faculty of medicine, Chiang mai university, Thailand'}}}}