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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2007 by University of Southern California. Recruitment status was Active, not recruiting

First Received on April 4, 2007. Last Updated on March 24, 2009 History of Changes

Sponsor:	University of Southern California
Collaborator:	AstraZeneca
Information provided by:	University of Southern California
ClinicalTrials.gov Identifier:	NCT00457366

Purpose

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.

Condition	Intervention	Phase
Agitation	Drug: Quetiapine Drug: Cocktail (Haloperidol, Lorazepam, Cogentin)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study 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.

Resource links provided by NLM:

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Benztropine Quetiapine Quetiapine fumarate Benzatropine methanesulfonate Lorazepam

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:

Decrease in the PANSS-EC two hours after administration of the medication. [ Time Frame: Two hours ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Quetiapine	Drug: Quetiapine 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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

English or Spanish speaking patients
Provision of written informed consent-English and Spanish
Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included.
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.
Ability, in the treating physician's opinion, to co-operate with taking oral medication

Exclusion Criteria:

Pregnant females who will thus receive routine care in the treating physician's opinion
Unstable medical illness
Withdrawal stage from any illicit drugs
Psychosis that prohibits participation in trial
Females of childbearing age where pregnancy cannot be confirmed or denied by screening
Patients who required continued intervention or prolonged restraint

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457366

Locations

United States, California
Los Angeles County Hospital
LA, California, United States, 90033

Sponsors and Collaborators

University of Southern California

AstraZeneca

Investigators

Principal Investigator:

George M Simpson, MD

USC+LAC Medical Center

More Information

No publications provided

Responsible Party:	George M.Simpson,MD, USC+LAC Medical Center
ClinicalTrials.gov Identifier:	NCT00457366 History of Changes
Other Study ID Numbers:	HS-05-00331
Study First Received:	April 4, 2007
Last Updated:	March 24, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Emergencies
Psychomotor Agitation
Disease Attributes
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Benztropine
Haloperidol
Lorazepam
Haloperidol decanoate
Quetiapine

Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012