Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Unity Health Toronto

Status and phase: Completed; Phase 4

Conditions: Agitation

Treatments: Drug: Placebo; Drug: Asenapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01400113

P00184

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Asenapine

Experimental group

Description:

This group received 10mg asenapine sl x 1 dose

Treatment:

Drug: Asenapine

Placebo

Placebo Comparator group

Description:

This group received placebo sl x 1 dose

Treatment:

Drug: Placebo