NYMC Faculty Publications

A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Trial of Sublingual Asenapine for Acute Agitation

Author Type(s)

Faculty

DOI

10.1111/acps.12262

Journal Title

Acta Psychiatrica Scandinavica

First Page

61

Last Page

68

Document Type

Article

Publication Date

7-1-2014

Department

Psychiatry and Behavioral Sciences

Keywords

Administration, Sublingual, Adolescent, Adult, Antipsychotic Agents, Dibenzocycloheptenes, Double-Blind Method, Female, Heterocyclic Compounds, 4 or More Rings, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Psychomotor Agitation, Time Factors, Treatment Outcome, Young Adult

Disciplines

Medicine and Health Sciences

Abstract

OBJECTIVE: To assess sublingual asenapine for acute agitation.

METHOD: Agitated adults 18-65 years (any diagnosis) presenting for treatment in an emergency department and found to have a score of ≥14 on the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) were randomized to receive either a single dose of a sublingual 10 mg tablet of asenapine or placebo. Primary outcome measure was change in the PANSS-EC score from baseline to 2 h after medication or placebo administration. Secondary outcomes included the percentage of responders with a ≥ 40% reduction from baseline on the PANSS-EC score at 2 h.

RESULTS: A total of 120 subjects were randomized, 60 each to sublingual asenapine or placebo. Mean (SE) baseline PANSS-EC scores for the asenapine-treated and placebo-treated subjects were 19.4 ± 0.66 and 20.1 ± 0.61, respectively. Mean PANSS-EC scores at endpoint (LOCF) was 7.4 ± 0.65 for the asenapine-treated subjects and 14.7 ± 0.98 for the placebo-treated subjects. Change in PANSS-EC score at 2 h was statistically significantly greater for the asenapine-treated subjects compared with the placebo-treated subjects. NNT for response vs. placebo was 3 (95% CI 2-4).

CONCLUSION: Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics.

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