Phase 4
N=120
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
Agitation
Bottom Line
View on ClinicalTrials.gov: NCT01400113 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Positive and Negative Syndrome Scale - Excited Component — 7.86; 14.93 PANSS SCORE
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Asenapine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Syndrome Scale - Excited Component |
7.86; 14.93 | — |
| SECONDARY Clinical Global Impression Scale |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01400113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.