Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

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.

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