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A single‐dose, randomized, double‐blind, placebo‐controlled trial of sublingual asenapine for acute agitation
Author(s) -
Pratts M.,
Citrome L.,
Grant W.,
Leso L.,
Opler L. A.
Publication year - 2014
Publication title -
acta psychiatrica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.849
H-Index - 146
eISSN - 1600-0447
pISSN - 0001-690X
DOI - 10.1111/acps.12262
Subject(s) - placebo , asenapine , medicine , positive and negative syndrome scale , randomized controlled trial , sublingual administration , clinical endpoint , anesthesia , schizophrenia (object oriented programming) , psychiatry , antipsychotic , psychosis , alternative medicine , pathology
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.