Who is sponsoring NCT01485692?

NCT01485692 is sponsored by University of Sao Paulo.

What condition does NCT01485692 study?

NCT01485692 studies Psychomotor Agitation.

What drugs are being tested in NCT01485692?

Interventions: haloperidol+promethazine, haloperidol + midazolam, olanzapine, Ziprasidone.

What is the status of NCT01485692?

NCT01485692 is currently COMPLETED.

Last reviewed 2011-12-01 · How we verify

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

NCT01485692 NA COMPLETED

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.

Details

Lead sponsor	University of Sao Paulo
Phase	NA
Status	COMPLETED
Enrolment	120
Start date	2009-02
Completion	2011-03

Conditions

Psychomotor Agitation

Interventions

haloperidol+promethazine
haloperidol + midazolam
olanzapine
Ziprasidone

Primary outcomes

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.

Countries

Brazil