Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-02-10 @ 8:43 AM
Study NCT ID:
NCT02504450
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Antipsychotic Medication Used in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D012559', 'term': 'Schizophrenia'}], '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'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008152', 'term': 'Loxapine'}, {'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'C092292', 'term': 'ziprasidone'}], 'ancestors': [{'id': 'D003989', 'term': 'Dibenzoxazepines'}, {'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'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-02', 'studyFirstSubmitDate': '2015-07-17', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay in the emergency department', 'timeFrame': 'Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.', 'description': 'We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.'}], 'secondaryOutcomes': [{'measure': 'Disposition', 'timeFrame': 'Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.', 'description': 'disposition (home, transfer, admit), and time to disposition'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bipolar 1 disorder', 'schizophrenia'], 'conditions': ['Agitation,Psychomotor']}, 'referencesModule': {'references': [{'pmid': '20528148', 'type': 'RESULT', 'citation': 'Dinh KV, Myers DJ, Noymer PD, Cassella JV. In vitro aerosol deposition in the oropharyngeal region for Staccato loxapine. J Aerosol Med Pulm Drug Deliv. 2010 Aug;23(4):253-60. doi: 10.1089/jamp.2009.0814.'}, {'pmid': '25210413', 'type': 'RESULT', 'citation': 'Valdes J, Shipley T, Rey JA. Loxapine inhalation powder (adasuve): a new and innovative formulation of an antipsychotic treatment for agitation. P T. 2014 Sep;39(9):621-3, 648.'}]}, 'descriptionModule': {'briefSummary': 'To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.', 'detailedDescription': 'A retrospective chart review will be performed for all patients presenting to the ED with agitation and subsequently given antipsychotic therapy for treatment. Identification of patients will be through chart review of patients presenting with agitation. Data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. Inclusion criteria include all patients over age 18 presenting to the ED with agitation and treated with antipsychotics. No patients will be knowingly excluded from analysis. We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'subjects treated in the emergency department for agitation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients given antipsychotic therapy for acute agitation\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02504450', 'acronym': 'OAMED', 'briefTitle': 'Outcomes of Antipsychotic Medication Used in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study', 'orgStudyIdInfo': {'id': 'AHC6066'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adasuve', 'type': 'DRUG', 'otherNames': ['Loxapine'], 'description': 'Inhaled medication to treat acute agitation in the emergency department'}, {'name': 'Alternative medications', 'type': 'DRUG', 'otherNames': ['Haloperidol, Serenace, Peridol, Haldon, Geodon, Ziprasidone'], 'description': 'Medication given to treat acute agitation in the emergency department'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erik Kulstad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advocate Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}