Status:
COMPLETED
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Schering-Plough
Conditions:
Agitation
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01400113
Start Date
April 1 2012
End Date
December 1 2012
Last Update
May 16 2016
Active Locations (1)
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1
St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)
Syracuse, New York, United States, 13203