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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine | Active Comparator | Quetiapine is being used in an ER setting on agitated patients, being administered orally. |
|
| Haloperidol | Active Comparator | "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. |
|
| Lorazepam | Active Comparator | "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 | Active Comparator | "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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | 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 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George M Simpson, MD | USC+LAC Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County Hospital | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine | 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. |
| FG001 | "Cocktail" Consisting of Haloperidol, Lorazepam, Cogentin | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
72 patients were included in the study. 4 patients were randomized to the Haloperidol cocktail group but were excluded from the analysis because they only had demographic data. Analyses were performed on the resulting 68 patients who had clinical outcome data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine | 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 |
| BG001 | Cocktail |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Two hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr George Simpson | USC | 7604687106 | gsimpson@usc.edu |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D006220 | Haloperidol |
| D008140 | Lorazepam |
| D001590 | Benztropine |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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|
| Haloperidol | Drug | given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary |
|
|
| Lorazepam | Drug | given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary. |
|
|
| Cogentin | Drug | given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary. |
|
|
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cocktail (Haloperidol, Lorazepam, Cogentin): Haloperidol 5 mg im, Lorazepam 2 mg im, Cogentin 2 mg im; repeated at 2 hours as deemed clinically necessary. |
| OG001 | Quetiapine | Quetiapine 300 mg PO |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Cocktail | 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 | 0 | 32 | 0 | 32 |
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| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |