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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine | Experimental | This group received 10mg asenapine sl x 1 dose |
|
| Placebo | Placebo Comparator | This group received placebo sl x 1 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | Asenapine Sublingual Tablet 10mg, single-dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Scale | Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Pratts, MD | St. Joseph's Hospital Health Center - CPEP | Principal Investigator |
| Laura Leso, MD | St. Joseph's Hospital Health Center - CPEP | Principal Investigator |
| David Frey, MD | St. Joseph's Hospital Health Center - CPEP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP) | Syracuse | New York | 13203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24606117 | Derived | Pratts M, Citrome L, Grant W, Leso L, Opler LA. A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation. Acta Psychiatr Scand. 2014 Jul;130(1):61-8. doi: 10.1111/acps.12262. Epub 2014 Mar 10. |
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All data available upon request.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine | 60 patients were randomized to this group |
| FG001 | Placebo | 60 patients were randomized to this group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | 60 patients were randomized to this group |
| BG001 | Placebo | 60 patients were randomized to this group |
| 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 | 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. | Posted | Mean | 95% Confidence Interval | PANSS SCORE | Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration. |
|
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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 | Asenapine | Asenapine: Asenapine Sublingual Tablet 10mg, single-dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Pratts, MD | St. Joseph's Hospital Health Center | 315-726-8610 | michael.pratts@sjhsyr.org |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Placebo | Drug | Placebo Sublingual Tablet, single-dose |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | 60 patients were randomized to this group |
|
|
| 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. | Not Posted | 2 hours |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Placebo | Placebo: Placebo Sublingual Tablet, single-dose | 0 | 60 | 0 | 60 |
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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 |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |