Agitation
Conditions
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.
Interventions
DRUGQuetiapine
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
DRUGHaloperidol
given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary
DRUGLorazepam
given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.
DRUGCogentin
given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.
Sponsors
AstraZeneca
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 34 |
| Total | 72 |
Baseline characteristics
| Characteristic | Cocktail | Quetiapine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 38 Participants | 72 Participants |
| Age, Continuous | 35.8 years | 36.1 years | 36.0 years |
| Region of Enrollment United States | 34 participants | 38 participants | 72 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 15 Participants |
| Sex: Female, Male Male | 28 Participants | 29 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 32 |
| serious Total, serious adverse events | 0 / 40 | 0 / 32 |
Outcome results
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).
Time frame: Two hours
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Cocktail | Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication. | -11.0 score on a scale | Standard Error 0.82 |
| Quetiapine | Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication. | -11.5 score on a scale | Standard Error 0.69 |
p-value: >0.05ANCOVA