Clinical trial NCT00457366
Conditions: Agitation
Sponsor: University of Southern California
Start date: 2006-05-01; Completion date: 2009-05-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

Detailed description:
In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

This study is designed to compare the efficacy and safety of Quetiapine with the routine "cocktail for treatment of agitation.

The primary purpose of this study is to determine the efficacy and safety of Quetiapine by using high dose Quetiapine (300 mg) PO to treat agitated patients in the psychiatric emergency room.

The secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.

Arms: arm 1: Quetiapine is being used in an ER setting on agitated patients, being administered orally. arm 2: "Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. arm 3: "Lorazepam" is being used in an ER setting on agitated patients, administered IM.This is being used in combination with haloperidol, and cogentin. We are comparing the use of this "cocktail" to quetiapine alone. arm 4: "Cogentin" is being used in an ER setting on agitated patients, administered IM.

This is being used in combination with haloperidol, and lorazepam. We are comparing the use of this "cocktail" to quetiapine alone.
Interventions: intervention 1: Quetiapine intervention 2: Haloperidol intervention 3: Lorazepam intervention 4: Cogentin
Intervention descriptions: intervention 1: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD intervention 2: given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary intervention 3: given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary. intervention 4: given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.

Protocol documents: