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

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Agitation

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

Phase: Phase 4

Status: Completed

Sponsored by: University of Southern California

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


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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Decrease in the PANSS-EC two hours after administration of the medication.


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


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

Locations and Contacts

Los Angeles County Hospital, Los Angeles, California 90033, United States
Additional Information

Starting date: May 2006
Last updated: January 29, 2014

Page last updated: August 23, 2015

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