Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

Agitation Clinical Trial

Official title:

Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400113
• Other study ID #: P00184
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2011
• Last updated: January 16, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: St. Joseph Hospital Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agitation

Intervention

Drug:
• Asenapine
Asenapine Sublingual Tablet 10mg, single-dose
• Placebo
Placebo Sublingual Tablet, single-dose

Locations

Country	Name	City	State
United States	St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph Hospital Health Center	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale - Excited Component	The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration.	2 hours	No
Secondary	Clinical Global Impression Scale	Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.	2 hours	No