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Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Michael J. Pratts, M.D., St. Joseph Hospital Health Center
ClinicalTrials.gov Identifier:
NCT01400113
First received: July 18, 2011
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Agitation
 Drug: Asenapine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial

Resource links provided by NLM:

Drug Information available for: Asenapine
U.S. FDA Resources

Further study details as provided by St. Joseph Hospital Health Center:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale - Excited Component [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impression Scale [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.


Enrollment: 120
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine Drug: Asenapine
Asenapine Sublingual Tablet 10mg, single-dose
Other Name: Saphris
Placebo Comparator: Placebo Drug: Placebo
Placebo Sublingual Tablet, single-dose
Other Name: Sugar Pill

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400113

Locations
United States, New York
St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)
Syracuse, New York, United States, 13203
Sponsors and Collaborators
St. Joseph Hospital Health Center
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
  More Information

No publications provided

Responsible Party: Michael J. Pratts, M.D., Psychiatrist, St. Joseph Hospital Health Center
ClinicalTrials.gov Identifier: NCT01400113     History of Changes
Other Study ID Numbers: P00184
Study First Received: July 18, 2011
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Joseph Hospital Health Center:
Acute Agitation

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Asenapine
 Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013