Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Completed · Phase 4 · Has a placebo group

Conditions studied: Agitation

In brief

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.

Key facts

Study ID

NCT01400113

Run by

Unity Health Toronto

People needed

120

Starts

2012-04-01

Expected to finish

2012-12-01

Last updated by the study team

2016-05-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP) — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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