A single‐dose, randomized, double‐blind, placebo‐controlled trial of sublingual asenapine for acute agitation. (10th March 2014)

• Record Type: Journal Article
• Authors: Pratts, M.; Citrome, L.; Grant, W.; Leso, L.; Opler, L. A.
• Is Part Of: Acta psychiatrica Scandinavica. Volume 130:Number 1(2014:Jul.)
• Page Start: 61
• Page End: 68
• Publication Date: 2014-03-10
• Subjects: Psychiatry -- Periodicals; 616.89
• DOI: 10.1111/acps.12262
• Languages: English
• ISSNs: 0001-690X

Abstract

<abstract abstract-type="main" id="acps12262-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="acps12262-sec-0001" sec-type="section"> <title>Objective</title> <p>To assess sublingual asenapine for acute agitation.</p> </sec> <sec id="acps12262-sec-0002" sec-type="section"> <title>Method</title> <p>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.</p> </sec> <sec id="acps12262-sec-0003" sec-type="section"> <title>Results</title> <p>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).</p> </sec> <sec id="acps12262-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics.</p> </sec> </abstract>