A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 4 |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Quetiapine Quetiapine is being used in an ER setting on agitated patients, being administered orally. |
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
Other Names:
|
Active Comparator: 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. |
Drug: Haloperidol
given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
Other Names:
|
Active Comparator: 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. |
Drug: Lorazepam
given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
Other Names:
|
Active Comparator: 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. |
Drug: Cogentin
given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Los Angeles County Hospital | Los Angeles | California | United States | 90033 |
Sponsors and Collaborators
- University of Southern California
- AstraZeneca
Investigators
- Principal Investigator: George M Simpson, MD, USC+LAC Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-05-00331
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Quetiapine | "Cocktail" Consisting of Haloperidol, Lorazepam, Cogentin |
---|---|---|
Arm/Group Description | Quetiapine is being compared to a "cocktail" consisting of haloperidol, lorazepam, and cogentin to see which works best in agitated patients that are being brought into the ER. | This "cocktail" consisting of haloperidol, lorazepam, and cogentin is being compared to quetiapiene to see which works best in agitated patients that are being brought into the ER. |
Period Title: Overall Study | ||
STARTED | 40 | 32 |
COMPLETED | 40 | 32 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Quetiapine | Cocktail | Total |
---|---|---|---|
Arm/Group Description | Quetiapine Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD | Cocktail (Haloperidol, Lorazepam, Cogentin) Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary | Total of all reporting groups |
Overall Participants | 38 | 34 | 72 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
38
100%
|
34
100%
|
72
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
36.1
|
35.8
|
36.0
|
Sex: Female, Male (Count of Participants) | |||
Female |
9
23.7%
|
6
17.6%
|
15
20.8%
|
Male |
29
76.3%
|
28
82.4%
|
57
79.2%
|
Region of Enrollment (participants) [Number] | |||
United States |
38
100%
|
34
100%
|
72
100%
|
Outcome Measures
Title | Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication. |
---|---|
Description | 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). |
Time Frame | Two hours |
Outcome Measure Data
Analysis Population Description |
---|
34 patients received the Cocktail, but 4 of these were excluded from the analysis because they had only demographic data and no clinical outcome data. A total of 38 patients received Quetiapine; all were included in the analysis. |
Arm/Group Title | Cocktail | Quetiapine |
---|---|---|
Arm/Group Description | Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary. | Quetiapine 300 mg PO |
Measure Participants | 30 | 38 |
Least Squares Mean (Standard Error) [score on a scale] |
-11.0
(0.82)
|
-11.5
(0.69)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Cocktail, Quetiapine |
---|---|---|
Comments | ||
Type of Statistical Test | Other | |
Comments | We used an analysis of covariance (ANCOVA) with baseline as the covariate to analyze the PANSS-EC at hour 2. | |
Statistical Test of Hypothesis | p-Value | >0.05 |
Comments | ||
Method | ANCOVA | |
Comments |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Quetiapine | Cocktail | ||
Arm/Group Description | Quetiapine Quetiapine: Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary upto a maximum dose of Quetiapine 600mg PO QD | Cocktail (Haloperidol, Lorazepam, Cogentin) Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary | ||
All Cause Mortality |
||||
Quetiapine | Cocktail | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Quetiapine | Cocktail | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/32 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Quetiapine | Cocktail | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/40 (0%) | 0/32 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr George Simpson |
---|---|
Organization | USC |
Phone | 7604687106 |
gsimpson@usc.edu |
- HS-05-00331