A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room

Condition(s) targeted: Agitation

Intervention: Quetiapine, Cocktail ( Haloperidol, Lorazepam, Cogentin) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
George M Simpson, MD, Principal Investigator, Affiliation: USC+LAC Medical Center

Overall contact:
George M. Simpson, MD, Phone: (323) 226 5363, Email: gsimpson@usc.edu

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.

Official title: A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.

Study design: Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. English or Spanish speaking patients

2. Provision of written informed consent-English and Spanish

3. Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.

4. Provision at diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) criteria for Axis I documented who present in an agitated state. PANSS-EC score should be >15.

5. Ability, in the treating physician's opinion, to co-operate with taking oral medication

Exclusion Criteria:

1. Pregnant females who will thus receive routine care in the treating physician's opinion

2. Unstable medical illness

3. Withdrawal stage from any illicit drugs

4. Psychosis that prohibits participation in trial

5. Females of childbearing age where pregnancy cannot be confirmed or denied by screening

6. Patients who required continued intervention or prolonged restraint

George M. Simpson, MD, Phone: (323) 226 5363, Email: gsimpson@usc.edu

Los Angeles County Hospital, LA, California 90033, United States; Recruiting
George M Simpson, MD, Principal Investigator

Starting date: May 2006
Last updated: September 20, 2007