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

Tracking Information

First Received Date ^ICMJE

April 4, 2007

Last Updated Date

March 24, 2009

Start Date ^ICMJE

May 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00457366 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Agitation

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: Quetiapine
Active Comparator: Cocktail (Haloperidol, Lorazepam, Cogentin)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

May 2009

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00457366

Responsible Party

George M.Simpson,MD, USC+LAC Medical Center

Study ID Numbers ^ICMJE

HS-05-00331

Study Sponsor ^ICMJE

University of Southern California

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

George M Simpson, MD

USC+LAC Medical Center

Information Provided By

University of Southern California

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP