A single-dose, randomized, double-blind, placebo-controlled trial of sublingual asenapine for acute agitation.
Acta Psychiatr Scand
; 130(1): 61-8, 2014 Jul.
Article
em En
| MEDLINE
| ID: mdl-24606117
ABSTRACT
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Agitação Psicomotora
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Antipsicóticos
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Compostos Heterocíclicos de 4 ou mais Anéis
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Acta Psychiatr Scand
Ano de publicação:
2014
Tipo de documento:
Article
País de afiliação:
Estados Unidos