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Treating Acutely Agitated Patients With Asenapine Sublingual Tablets

NCT01400113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-05-16

Study results available
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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

Interventions

DRUG

Asenapine

Asenapine Sublingual Tablet 10mg, single-dose

DRUG

Placebo

Placebo Sublingual Tablet, single-dose

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Michael J Pratts, MD · St. Joseph's Hospital Health Center - CPEP

  • Laura Leso, MD · St. Joseph's Hospital Health Center - CPEP

  • David Frey, MD · St. Joseph's Hospital Health Center - CPEP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400113 on ClinicalTrials.gov