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

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01485692

Collaborator

(none)

120

Enrollment

Location

Arms

24.9

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychomotor Agitation	Drug: haloperidol+promethazine Drug: haloperidol + midazolam Drug: olanzapine Drug: Ziprasidone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Four Intramuscular Interventions for the Management of Acute Psychomotor Agitation

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Reduction in the agitation score [90 minutes]
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 [12,24 hours after baseline]
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.