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

NCT ID: NCT01485692

Last Updated: 2011-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Psychomotor Agitation

Keywords

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Violence Aggression Psychiatric emergencies Psychomotor agitation Violent patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ziprasidone injection

ziprasidone injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of the observation

Group Type ACTIVE_COMPARATOR

Ziprasidone

Intervention Type DRUG

ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation

haloperidol + midazolam, injection

Haloperidol plus midazolam injection, after baseline measures of agitation,allowed to be repeated twice over the 90 minutes period of observation

Group Type ACTIVE_COMPARATOR

haloperidol + midazolam

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

haloperidol+promethazine

Intervention Type DRUG

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

olanzapine, injection

olanzapine, 10mg, intramuscular injection after baseline measures of agitation, could be repeated twice if necessary, between the 90 minutes of observation

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation

Interventions

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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

Intervention Type 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

Intervention Type DRUG

olanzapine

olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Celia Mantovani

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celia Mantovani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto, USP

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 23609398 (View on PubMed)

Other Identifiers

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UE0001

Identifier Type: -

Identifier Source: org_study_id