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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457366
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : January 31, 2014
Information provided by (Responsible Party):
George Simpson, University of Southern California

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.

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 or disease Intervention/treatment Phase
Agitation Drug: Quetiapine Drug: Cocktail (Haloperidol, Lorazepam, Cogentin) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : May 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: 1
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

Primary Outcome Measures :
  1. Decrease in the PANSS-EC two hours after administration of the medication. [ Time Frame: Two hours ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457366

United States, California
Los Angeles County Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: George M Simpson, MD USC+LAC Medical Center

Responsible Party: George Simpson, Principal Investigator, University of Southern California Identifier: NCT00457366     History of Changes
Other Study ID Numbers: HS-05-00331
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: January 31, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Quetiapine Fumarate
Haloperidol decanoate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Hypnotics and Sedatives
Anti-Anxiety Agents
GABA Modulators
GABA Agents
Antiparkinson Agents
Muscarinic Antagonists