Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial|
- Positive and Negative Syndrome Scale - Excited Component [ Time Frame: 2 hours ] [ Designated as safety issue: No ]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.
- Clinical Global Impression Scale [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.
|Study Start Date:||April 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Asenapine Sublingual Tablet 10mg, single-dose
Other Name: Saphris
|Placebo Comparator: Placebo||
Placebo Sublingual Tablet, single-dose
Other Name: Sugar Pill
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.
|United States, New York|
|St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)|
|Syracuse, New York, United States, 13203|
|Principal Investigator:||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|