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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Agitation

Intervention / Treatment
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* Drug: Quetiapine
* Drug: Haloperidol
* Drug: Lorazepam
* Drug: Cogentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English or Spanish speaking patients Provision of written informed consent-English and Spanish Males and females age 18 to 60 years. Females who are pregnant by inspection should not be included. 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. Ability, in the treating physician's opinion, to co-operate with taking oral medication Exclusion Criteria: Pregnant females who will thus receive routine care in the treating physician's opinion Unstable medical illness Withdrawal stage from any illicit drugs Psychosis that prohibits participation in trial Females of childbearing age where pregnancy cannot be confirmed or denied by screening Patients who required continued intervention or prolonged restraint

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quetiapine<br>Quetiapine is being used in an ER setting on agitated patients, being administered orally. | Drug: Quetiapine<br>* 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<br>* Other names: no other name;|
| Active Comparator: Haloperidol<br>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. | Drug: Haloperidol<br>* given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary<br>* Other names: no other names;|
| Active Comparator: Lorazepam<br>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. | Drug: Lorazepam<br>* given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.<br>* Other names: no other name;|
| Active Comparator: Cogentin<br>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. | Drug: Cogentin<br>* given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.<br>* Other names: no other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |