Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

NCT01400113 | Completed Phase 4 Results DMC

• 1 other identifier: P00184
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation

Keywords

Acute Agitation; schizophrenia; bipolar; psychosis; panss-ec

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Global Impression Scale

  2 hours

Study Arms (2)

Asenapine

EXPERIMENTAL

This group received 10mg asenapine sl x 1 dose

Drug: Asenapine

Placebo

PLACEBO COMPARATOR

This group received placebo sl x 1 dose

Drug: Placebo

Interventions

Asenapine DRUG

Asenapine Sublingual Tablet 10mg, single-dose

Also known as: Saphris

Asenapine

Placebo DRUG

Placebo Sublingual Tablet, single-dose

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Schering-Plough: collaborator

Study Sites (1)

St. Joseph's Hospital Health Center-Comprehensive Psychiatric Emergency Program (CPEP)

Syracuse, New York, 13203, United States

Location

Related Publications (1)

• 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.

  PMID: 24606117 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Schizophrenia; Psychotic Disorders

Interventions

asenapine; Sugars

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

1. The short observation period of 2 hours. 2. Dependence on spontaneous self reporting of adverse effects. 3. Specific inquiry was not made regarding adverse events.

Results Point of Contact

• Title: Michael Pratts, MD
• Organization: St. Joseph's Hospital Health Center

michael.pratts@sjhsyr.org

315-726-8610

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 22, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 16, 2016
• Results First Posted: May 16, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)