Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

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

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.

Study Overview

• Status: Completed
• Conditions: Agitation
• Intervention / Treatment: Drug: Asenapine; Drug: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13203
      • St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asenapine; This group received 10mg asenapine sl x 1 dose	Drug: Asenapine; Asenapine Sublingual Tablet 10mg, single-dose; Other Names: Saphris
Placebo Comparator: Placebo; This group received placebo sl x 1 dose	Drug: Placebo; Placebo Sublingual Tablet, single-dose; Other Names: Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies.	Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Schering-Plough
• Investigators: Principal Investigator: Michael J Pratts, MD, St. Joseph's Hospital Health Center - CPEP; Principal Investigator: Laura Leso, MD, St. Joseph's Hospital Health Center - CPEP; Principal Investigator: David Frey, MD, St. Joseph's Hospital Health Center - CPEP

Publications and helpful links

General Publications

• Pratts M, Citrome L, Grant W, Leso L, Opler LA. A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation. Acta Psychiatr Scand. 2014 Jul;130(1):61-8. doi: 10.1111/acps.12262. Epub 2014 Mar 10.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: schizophrenia; psychosis; bipolar; Acute Agitation; panss-ec
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Asenapine
• Other Study ID Numbers: P00184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data available upon request.