Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT00786318
Status:
WITHDRAWN
Last Update Posted:
2017-09-25
First Post:
2008-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092292', 'term': 'ziprasidone'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor terminated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2008-11-05', 'studyFirstSubmitQcDate': '2008-11-05', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of time from triage until patient is either ready to be seen by psychiatry or is ready to have a disposition made', 'timeFrame': 'During ED stay'}], 'secondaryOutcomes': [{'measure': 'Length of time taken to sedate patient', 'timeFrame': 'Ed visit'}, {'measure': 'Total time spent in restraints', 'timeFrame': 'ED visit'}, {'measure': 'Cost effectiveness of the therapy', 'timeFrame': 'ED visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychosis', 'Agitation', 'Delirium'], 'conditions': ['Psychosis', 'Agitation', 'Delirium']}, 'referencesModule': {'references': [{'pmid': '16387220', 'type': 'BACKGROUND', 'citation': 'Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. doi: 10.1016/j.annemergmed.2005.08.025. Epub 2005 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if ziprasidone is superior to standard therapies in the emergency department treatment of the acutely agitated patient. The primary outcome will be the length of time taken until the patient is ready to be evaluated by the psychiatric service, or until a disposition is made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acutely agitated\n* Requires chemical sedation\n\nExclusion Criteria:\n\n* Physician preference for a specific chemical sedative\n* Known allergy to any study medications'}, 'identificationModule': {'nctId': 'NCT00786318', 'briefTitle': 'Ziprasidone vs Standard Therapy for Agitated Patients in the ED', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Prospective Double Blind Randomized Trial of Intramuscular Ziprasidone Compared With Standard Antipsychotic Therapy For The Treatment Of The Acutely Agitated Patient In The Emergency Department', 'orgStudyIdInfo': {'id': '010411 (completed)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ziprasidone', 'interventionNames': ['Drug: ziprasidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'interventionNames': ['Drug: Standard therapy']}], 'interventions': [{'name': 'ziprasidone', 'type': 'DRUG', 'description': 'ziprasidone 20mg IM', 'armGroupLabels': ['ziprasidone']}, {'name': 'Standard therapy', 'type': 'DRUG', 'description': 'Haldol 5mg/ Ativan 2mg IM', 'armGroupLabels': ['Standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The George Washington University Medical Center, Dept of Emergency Medicine', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jeremy Brown', 'oldOrganization': 'Dept of Emergency Medicine, The George Washington University Medical Center'}}}}