title: A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation.
abstract: OBJECTIVE
  To assess sublingual asenapine for acute agitation.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  Sublingual asenapine was efficacious in the treatment of agitation with an effect size comparable to that observed in prior studies of intramuscular antipsychotics.
authors.affiliation: St. Joseph's Hospital Health Center, Syracuse, NY, USA.
authors.forename: M
authors.initials: M
authors.lastname: Pratts
authors.forename: L
authors.initials: L
authors.lastname: Citrome
authors.forename: W
authors.initials: W
authors.lastname: Grant
authors.forename: L
authors.initials: L
authors.lastname: Leso
authors.forename: L A
authors.initials: LA
authors.lastname: Opler
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003986:Dibenzocycloheptenes; D004311:Double-Blind Method; D005260:Female; D006576:Heterocyclic Compounds, 4 or More Rings / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011595:Psychomotor Agitation / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003986:Dibenzocycloheptenes; D006576:Heterocyclic Compounds, 4 or More Rings; C522667:asenapine
keywords: aggression; agitation; asenapine; psychopharmacology; psychoses