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

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457366
• Other study ID #: HS-05-00331
• Status: Completed
• Phase: Phase 4
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: April 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Emergencies

Intervention

Drug:
• Quetiapine
Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD
• Haloperidol
given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
• Lorazepam
given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
• Cogentin
given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.

Locations

Country	Name	City	State
United States	Los Angeles County Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.	The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores = 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011).	Two hours