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

University of Southern California

Status and phase: Completed; Phase 4

Conditions: Agitation

Treatments: Drug: Lorazepam; Drug: Cogentin; Drug: Quetiapine; Drug: Haloperidol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00457366

HS-05-00331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 4 patient groups

Quetiapine

Active Comparator group

Description:

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

Treatment:

Drug: Quetiapine

Haloperidol

Active Comparator group

Description:

"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.

Treatment:

Drug: Haloperidol

Lorazepam

Active Comparator group

Description:

"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.

Treatment:

Drug: Lorazepam

Cogentin

Active Comparator group

Description:

"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.

Treatment:

Drug: Cogentin