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

NCT ID: NCT00457366

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-05-31

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.

Detailed 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.

Conditions

Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Quetiapine

Quetiapine is being used in an ER setting on agitated patients, being administered orally.

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

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

"Haloperidol" is being used in an ER setting on agitated patients, administered IM. This is being used in combination with lorazepam and cogentin. We are comparing the use of this "cocktail" to quetiapine alone.

Group Type: ACTIVE_COMPARATOR

Haloperidol

Intervention Type: DRUG

given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary

Lorazepam

"Lorazepam" is being used in an ER setting on agitated patients, administered IM.This is being used in combination with haloperidol, and cogentin. We are comparing the use of this "cocktail" to quetiapine alone.

Group Type: ACTIVE_COMPARATOR

Lorazepam

Intervention Type: DRUG

given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.

Cogentin

"Cogentin" is being used in an ER setting on agitated patients, administered IM.

This is being used in combination with haloperidol, and lorazepam. We are comparing the use of this "cocktail" to quetiapine alone.

Group Type: ACTIVE_COMPARATOR

Cogentin

Intervention Type: DRUG

given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.

Interventions

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

Intervention Type: DRUG

Haloperidol

given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary

Intervention Type: DRUG

Lorazepam

given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.

Intervention Type: DRUG

Cogentin

given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.

Intervention Type: DRUG

Other Intervention Names

no other name; no other names; no other name; no other name

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George M Simpson, MD

Role: PRINCIPAL_INVESTIGATOR

USC+LAC Medical Center

Locations

Los Angeles County Hospital

Los Angeles, California, United States

Countries

United States

Other Identifiers

HS-05-00331

Identifier Type: -

Identifier Source: org_study_id