Agitation
Conditions
Keywords
Acute Agitation, schizophrenia, bipolar, psychosis, panss-ec
Brief summary
Our proposal is to administer asenapine to patients who are clinically agitated and in need of immediate intervention. At present there are no controlled studies that we know of that explores the use of asenapine for this purpose. Establishing the utility of asenapine for this common clinical problem will support its use as an additional treatment option in acutely agitated patients.
Detailed description
A psychiatrist (blinded) will assess the patient for agitation and their capacity to consent. Patients will be informed about the study and asked to complete informed consent prior to being included in the study. Patients who decline will not be included. A nurse (blinded) will administer either 10mg asenapine or placebo sublingually in a randomized fashion. Efficacy in reducing acute agitation will be evaluated using the PANSS-EC. A trained rater (blinded) will rate patients at baseline and at 15, 30, 60, 90 and 120 minutes (or endpoint) after medication administration. Efficacy in reducing acute agitation will also be evaluated using the Clinical Global Impression Scale (CGI). A trained rater (blinded) will rate patients at baseline CGI-Severity and CGI-Change at 60 and 120 minutes (or endpoint) after medication administration. The need for additional medications, interventions or physical restraints will be recorded and constitute the endpoint for that patient. Demographics, diagnoses, blood alcohol level, urine toxicology, and urine pregnancy will be collected.
Interventions
DRUGAsenapine
Asenapine Sublingual Tablet 10mg, single-dose
DRUGPlacebo
Placebo Sublingual Tablet, single-dose
Sponsors
Schering-Plough
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients will be between the ages of 18 and 65 * Be acutely agitated as determined by a total score of ≧ 14 on the PANSS-EC and at least one individual item score of ≧ 4 * Patients must have the capacity to provide informed consent, and such consent will be obtained prior to participation
Exclusion criteria
* Patient is knowingly pregnant * Patient is less than 18 or greater than 65 years old * Patient had a past adverse or allergic response to Asenapine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale - Excited Component | Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration. | The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression Scale | 2 hours | Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales. |
Countries
United States
Participant flow
Recruitment details
Between 4/23/12 and 12/11/12, adult, non-pregnant patients in a Psychiatric Emergency Room were assessed by a psychiatrist for agitation. Those patients who were willing to participate and signed an informed consent were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Asenapine 60 patients were randomized to this group | 60 |
| Placebo 60 patients were randomized to this group | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Asenapine | 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 | 60 Participants | 60 Participants | 120 Participants |
| Age, Continuous | 36.4 years STANDARD_DEVIATION 12.4 | 36.3 years STANDARD_DEVIATION 11.1 | 36.4 years STANDARD_DEVIATION 11.75 |
| Region of Enrollment United States | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 24 Participants | 17 Participants | 41 Participants |
| Sex: Female, Male Male | 36 Participants | 43 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Positive and Negative Syndrome Scale - Excited Component
The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC 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.
Time frame: Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Asenapine | Positive and Negative Syndrome Scale - Excited Component | 7.86 PANSS SCORE |
| Placebo | Positive and Negative Syndrome Scale - Excited Component | 14.93 PANSS SCORE |
Secondary
Clinical Global Impression Scale
Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
Time frame: 2 hours