A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation
| Autor: | L. Leso, W. Grant, M. Pratts, Lewis A. Opler, Leslie Citrome |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Time Factors Adolescent Placebo-controlled study Administration Sublingual Dibenzocycloheptenes Placebo Heterocyclic Compounds 4 or More Rings Double blind Young Adult Double-Blind Method medicine Asenapine Humans Psychomotor Agitation Psychiatric Status Rating Scales business.industry Emergency department Middle Aged Psychiatry and Mental health Treatment Outcome Anesthesia Female business medicine.drug Antipsychotic Agents |
| Zdroj: | Acta psychiatrica Scandinavica. 130(1) |
| ISSN: | 1600-0447 |
| Popis: | Pratts M, Citrome L, Grant W, Leso L, Opler LA. A single-dose,randomized, double-blind, placebo-controlled trial of sublingualasenapine for acute agitation.Objective: To assess sublingual asenapine for acute agitation.Method: Agitated adults 18–65 years (any diagnosis) presenting fortreatment in an emergency department and found to have a score of≥14 on the Positive and Negative Syndrome Scale-ExcitedComponent (PANSS-EC) were randomized to receive either a singledose of a sublingual 10 mg tablet of asenapine or placebo. Primaryoutcome measure was change in the PANSS-EC score from baselineto 2 h after medication or placebo administration. Secondaryoutcomes 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 sublingualasenapine or placebo. Mean (SE) baseline PANSS-EC scores for theasenapine-treated and placebo-treated subjects were 19.4 0.66 and20.1 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 forthe placebo-treated subjects. Change in PANSS-EC score at 2 h wasstatistically significantly greater for the asenapine-treated subjectscompared with the placebo-treated subjects. NNT for response vs.placebo was 3 (95% CI 2–4).Conclusion: Sublingual asenapine was efficacious in the treatment ofagitation with an effect size comparable to that observed in prior studiesof intramuscular antipsychotics. |
| Databáze: | OpenAIRE |
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