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

NCT01485692 | Completed

• 1 other identifier: UE0001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychomotor Agitation

Keywords

Violence; Aggression; Psychiatric emergencies; Psychomotor agitation; Violent patient

Outcome Measures

Primary Outcomes (1)

• Reduction in the agitation score

  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.

  90 minutes

Secondary Outcomes (1)

• Adverse effects

  12,24 hours after baseline

Study Arms (4)

ziprasidone injection

ACTIVE COMPARATOR

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

Drug: Ziprasidone

haloperidol + midazolam, injection

ACTIVE COMPARATOR

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 + promethazine, injection

ACTIVE COMPARATOR

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

olanzapine, injection

ACTIVE COMPARATOR

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

Drug: olanzapine

Interventions

haloperidol+promethazine 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

haloperidol + promethazine, injection

haloperidol + midazolam 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 + midazolam, injection

olanzapine DRUG

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

olanzapine, injection

Ziprasidone DRUG

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

ziprasidone injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 23609398 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Aggression

Interventions

Haloperidol; Midazolam; Olanzapine; ziprasidone

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Celia Mantovani, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 5, 2011
• Study Start: February 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: December 5, 2011

Record last verified: 2009-02

Locations

BR (1)