Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:23 AM
Study NCT ID:
NCT03899506
Status:
TERMINATED
Last Update Posted:
2019-05-13
First Post:
2018-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olanzapine Versus Midazolam for Agitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Investigator Voluntary Pause', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2018-06-28', 'studyFirstSubmitQcDate': '2019-03-29', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Adequately Sedated at 15 minutes', 'timeFrame': '15 minutes', 'description': 'Proportion of patients who achieve an AMSS score of \\< 1 at 15 minutes'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Adequately Sedated at 30 minutes', 'timeFrame': '30 minutes', 'description': 'Proportion of patients who achieve an AMSS score of \\< 1 at 30 minutes'}, {'measure': 'Proportion of Patients Adequately Sedated at 60 minutes', 'timeFrame': '60 minutes', 'description': 'Proportion of patients who achieve an AMSS score of \\< 1 at 60 minutes'}, {'measure': 'Proportion of Patients Adequately Sedated at 120 minutes', 'timeFrame': '120 minutes', 'description': 'Proportion of patients who achieve an AMSS score of \\< 1 at 120 minutes'}, {'measure': 'Safety Events', 'timeFrame': '120 minutes', 'description': 'Proportion of patients who experience respiratory depression, hypotension, extrapyramidal side effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Agitation,Psychomotor']}, 'descriptionModule': {'briefSummary': 'The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.', 'detailedDescription': 'The goal of this research investigation is to conduct a prospective observation of the comparative efficacy of midazolam versus olanzapine for the treatment of acute undifferentiated agitation in the emergency department.\n\nIn the summer of 2017, the ED implemented a treatment protocol as a quality improvement initiative. The investigators performed observational research on this protocol and identified that haloperidol and ziprasidone were inferior to midazolam and olanzapine for treating agitation in our Department.\n\nThe comparison between olanzapine and midazolam, however, was inconclusive. It is possible that this is due to inadequate power, so the question of whether olanzapine or midazolam is superior is still unknown.\n\nBecause the department continues to strive to achieve the best care for this patient population, in the Summer of 2018 the ED is going to initiate a second ED treatment protocol of olanzapine and midazolam, based on the results of our 2017 protocol.\n\nAll patients requiring chemical sedation for will receive olanzapine as the initial treatment for agitation for 6 weeks, followed by midazolam as the initial treatment for agitation for 6 weeks. These patients will be observed by research staff.\n\nThis is a clinical care quality improvement protocol. The clinical protocol is not research. The research component is the observation of this clinical care protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ED patients with agitation who receive a medication per protocol at the discretion of ED providers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency Department patients\n* Patients 18 years and older\n* Patients with acute undifferentiated agitation requiring chemical sedation at the discretion of the attending emergency physician will be observed.\n\nPatients meeting these criteria who receive medications in the ED will be observed by research staff, evaluating efficacy and safety of the administered medication.\n\nExclusion Criteria:\n\n\\- There are no exclusion criteria per se as this is only observational research. The decision to administer the medication is at the discretion of the physician. Research protocols are only such that we are observing the efficacy and safety, which coincides the quality improvement purposes of this clinical protocol. Patients will be provided an Information Sheet and can opt to have their data removed.\n\nPatients who are prisoners, children, will NOT have their data collected'}, 'identificationModule': {'nctId': 'NCT03899506', 'acronym': 'OvM', 'briefTitle': 'Olanzapine Versus Midazolam for Agitation', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Prospective Observational Investigation of Olanzapine Versus Midazolam for the Treatment of Acute Undifferentiated Agitation in the Emergency Department', 'orgStudyIdInfo': {'id': 'HSR #18-4521'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Olanzapine', 'description': 'Patients receiving 10 mg IM Olanzapine per the ED protocol', 'interventionNames': ['Drug: Olanzapine']}, {'label': 'Midazolam', 'description': 'Patients receiving 5 mg IM Midazolam per the ED protocol', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'description': 'Patients receiving Olanzapine per the ED protocol', 'armGroupLabels': ['Olanzapine']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Patients receiving Midazolam per the ED protocol', 'armGroupLabels': ['Midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Lauren Klein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin County Medical Center, Minneapolis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lauren Klein', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}