Clinical trial NCT01400113: Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
Official title: Treating Acutely Agitated Patients With Asenapine Sublingual Tablets: A Single-Dose, Randomized, Double-Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitation
Keywords: Acute Agitation
schizophrenia
bipolar
psychosis
panss-ec
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2011-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Positive and Negative Syndrome Scale - Excited Component
timeFrame: Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.
Secondary outcomes:
measure: Clinical Global Impression Scale
timeFrame: 2 hours
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)
state: New York
Study officials:
affiliation: St. Joseph's Hospital Health Center - CPEP
name: Michael J Pratts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Hospital Health Center - CPEP
name: Laura Leso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Hospital Health Center - CPEP
name: David Frey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.