A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation
Article first published online: 10 MAR 2014
© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Acta Psychiatrica Scandinavica
Volume 130, Issue 1, pages 61–68, July 2014
How to Cite
A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation., , , , .
- Issue published online: 10 JUN 2014
- Article first published online: 10 MAR 2014
- Manuscript Accepted: 10 FEB 2014
- Merck & Co., Inc.. Grant Number: 39230
To assess sublingual asenapine for acute agitation.
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.
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).
Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics.