A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
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.
|Agitation||Drug: Quetiapine Drug: Cocktail (Haloperidol, Lorazepam, Cogentin)||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.|
- Decrease in the PANSS-EC two hours after administration of the medication. [ Time Frame: Two hours ]
|Study Start Date:||May 2006|
|Study Completion Date:||May 2009|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD
Active Comparator: 2
Cocktail (Haloperidol, Lorazepam, Cogentin)
Drug: Cocktail (Haloperidol, Lorazepam, Cogentin)
Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457366
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||George M Simpson, MD||USC+LAC Medical Center|