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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
George Simpson, University of Southern California
ClinicalTrials.gov Identifier:
NCT00457366
First received: April 4, 2007
Last updated: January 29, 2014
Last verified: January 2014

April 4, 2007
January 29, 2014
May 2006
August 2008   (final data collection date for primary outcome measure)
Decrease in the PANSS-EC two hours after administration of the medication. [ Time Frame: Two hours ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00457366 on ClinicalTrials.gov Archive Site
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A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Agitation
  • 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
  • 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
  • Active Comparator: 1
    Quetiapine
    Intervention: Drug: Quetiapine
  • Active Comparator: 2
    Cocktail (Haloperidol, Lorazepam, Cogentin)
    Intervention: Drug: Cocktail (Haloperidol, Lorazepam, Cogentin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
May 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00457366
HS-05-00331
Yes
George Simpson, University of Southern California
University of Southern California
AstraZeneca
Principal Investigator: George M Simpson, MD USC+LAC Medical Center
University of Southern California
January 2014

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