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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
History of Changes

November 28, 2011
December 1, 2011
February 2009
March 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01485692 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Four Interventions in the Management of Psychomotor Agitation, Safety and Efficacy Evaluation
Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Psychomotor Agitation
  • 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
  • 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
  • Drug: olanzapine
    olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of 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: ziprasidone injection
    ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation
    Intervention: Drug: Ziprasidone
  • 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
    Intervention: Drug: haloperidol + midazolam
  • 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
    Intervention: Drug: haloperidol+promethazine
  • 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
    Intervention: Drug: olanzapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01485692
UE0001
No
Celia Mantovani, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Celia Mantovani, MD University of Sao Paulo
University of Sao Paulo
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP