Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT01485692
Status:
COMPLETED
Last Update Posted:
2011-12-05
First Post:
2011-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D000374', 'term': 'Aggression'}], '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': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'C092292', 'term': 'ziprasidone'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-01', 'studyFirstSubmitDate': '2011-11-28', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the agitation score', 'timeFrame': '90 minutes', 'description': 'Agitation scores were evaluated through two previously validated specific scales: ACES ( Agitation Calmness Evaluating Scale) and PANSS-EC ( Positive and Negative Symptoms Scale- Excited Component). The measure was collected by a blind rater at baseline and the subsequent measures aimed to evaluate the drug effect over agitation scores.'}], 'secondaryOutcomes': [{'measure': 'Adverse effects', 'timeFrame': '12,24 hours after baseline', 'description': 'Aiming to evaluate the occurrence of adverse effects in the 24 hours period of observation after administrating the first injection (Baseline), an exert from the UKU scale (Ugvalg klinisk Undersgelser Side Effect Scale )was applied by a blind rater, to evaluate the presence and intensity of possible side effects.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Violence', 'Aggression', 'Psychiatric emergencies', 'Psychomotor agitation', 'Violent patient'], 'conditions': ['Psychomotor Agitation']}, 'referencesModule': {'references': [{'pmid': '23609398', 'type': 'DERIVED', 'citation': 'Mantovani C, Labate CM, Sponholz A Jr, de Azevedo Marques JM, Guapo VG, de Simone Brito dos Santos ME, Pazin-Filho A, Del-Ben CM. Are low doses of antipsychotics effective in the management of psychomotor agitation? A randomized, rated-blind trial of 4 intramuscular interventions. J Clin Psychopharmacol. 2013 Jun;33(3):306-12. doi: 10.1097/JCP.0b013e3182900fd6.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the efficacy and safety of four options of medications in the management of acute psychomotor agitation,or violence and aggression situations in health services. All of the treatment options are already approved and currently used for this purpose. The options are: haloperidol plus midazolam, haloperidol plus promethazine, olanzapine and ziprasidone. The investigators hypothesized that all treatment options are effective in the treatment of acute agitation, but the combination haloperidol plus promethazine could elicit more adverse affects than the others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients featuring psychomotor agitation, with clinical need for intramuscular injection\n\nExclusion Criteria:\n\n* delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options'}, 'identificationModule': {'nctId': 'NCT01485692', 'briefTitle': 'Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation', 'orgStudyIdInfo': {'id': 'UE0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ziprasidone injection', 'description': 'ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation', 'interventionNames': ['Drug: Ziprasidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'haloperidol + midazolam, injection', 'description': 'Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation', 'interventionNames': ['Drug: haloperidol + midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'haloperidol + promethazine, injection', 'description': 'haloperidol + promethazine injection after baseline measures of agitation, could be repeated after 30 minutes, and once more, if necessary, in the 90 minutes period of observation', 'interventionNames': ['Drug: haloperidol+promethazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'olanzapine, injection', 'description': 'olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation', 'interventionNames': ['Drug: olanzapine']}], 'interventions': [{'name': 'haloperidol+promethazine', 'type': 'DRUG', 'description': 'haloperidol, 2,5mg plus promethazine,25mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, in the 90 minutes period of observation', 'armGroupLabels': ['haloperidol + promethazine, injection']}, {'name': 'haloperidol + midazolam', 'type': 'DRUG', 'description': 'haloperidol, 2,5mg plus midazolam, 7,5 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation', 'armGroupLabels': ['haloperidol + midazolam, injection']}, {'name': 'olanzapine', 'type': 'DRUG', 'description': 'olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation', 'armGroupLabels': ['olanzapine, injection']}, {'name': 'Ziprasidone', 'type': 'DRUG', 'description': 'ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation', 'armGroupLabels': ['ziprasidone injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Celia Mantovani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Celia Mantovani', 'investigatorAffiliation': 'University of Sao Paulo'}}}}