Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celia Mantovani, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01485692
First received: November 28, 2011
Last updated: December 1, 2011
Last verified: February 2009
  Purpose

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.


Condition Intervention
Psychomotor Agitation
Drug: haloperidol+promethazine
Drug: haloperidol + midazolam
Drug: olanzapine
Drug: Ziprasidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Reduction in the agitation score [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse effects [ Time Frame: 12,24 hours after baseline ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 120
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ziprasidone injection
ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation
Drug: Ziprasidone
ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
Active Comparator: haloperidol + midazolam, injection
Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation
Drug: haloperidol + midazolam
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
Active Comparator: haloperidol + promethazine, injection
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
Drug: haloperidol+promethazine
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
Active Comparator: olanzapine, injection
olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation
Drug: olanzapine
olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients featuring psychomotor agitation, with clinical need for intramuscular injection

Exclusion Criteria:

  • delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485692

Locations
Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP
Ribeirão Preto, São Paulo, Brazil, 14048-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Celia Mantovani, MD University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celia Mantovani, Principal investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01485692     History of Changes
Other Study ID Numbers: UE0001
Study First Received: November 28, 2011
Last Updated: December 1, 2011
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Violence
Aggression
Psychiatric emergencies
Psychomotor agitation
Violent patient

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Promethazine
Diphenhydramine
Midazolam
Haloperidol
Olanzapine
Ziprasidone
Haloperidol decanoate
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2014