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

Phase 4

Completed

• Conditions: Agitation
• Interventions: Drug: Lorazepam; Drug: Cogentin; Drug: Quetiapine; Drug: Haloperidol

• Registration Number: NCT00457366
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-05
• Study First Posted: 2007-04-06
• Primary Completion: 2008-08
• Study Completion: 2009-05
• Results First Submitted: 2016-05-12
• Status Verified: 2017-04
• Results First Submitted QC: 2019-06-12
• Results First Posted: 2019-07-05
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lorazepam	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.
Cogentin	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.
Quetiapine	Quetiapine	Quetiapine is being used in an ER setting on agitated patients, being administered orally.
Haloperidol	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.

Primary Outcome Measures

Name	Time	Method
Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.	Two hours	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).

Trial Locations

Locations (1)

Los Angeles County Hospital; 🇺🇸 Los Angeles, California, United States