Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph Hospital Health Center; Unity Health Toronto
• Collaborator: Schering-Plough
• Treatments: Asenapine

Criteria

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