Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine.
Br J Psychiatry
; 198(1): 51-8, 2011 Jan.
Article
em En
| MEDLINE
| ID: mdl-21200077
ABSTRACT
BACKGROUND:
There is a need for a rapid-acting, non-injection, acute treatment for agitation.AIMS:
To evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.METHOD:
This phase III, randomised, double-blind, placebo-controlled, parallel-group study (ClinicalTrials.gov number NCT00628589) enrolled 344 individuals who received one, two or three doses of inhaled loxapine (5 or 10 mg) or a placebo. Lorazepam rescue was permitted after dose two. The primary efficacy end-point was change from baseline in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) 2 h after dose one. The key secondary end-point was Clinical Global Impression-Improvement scale (CGI-I) score 2 h after dose one.RESULTS:
Inhaled loxapine (5 and 10 mg) significantly reduced agitation compared with placebo as assessed by primary and key secondary end-points. Reduced PANSS-EC score was evident 10 min after dose one with both 5 and 10 mg doses. Inhaled loxapine was well tolerated, and the most common adverse events were known effects of loxapine or minor oral effects common with inhaled medications.CONCLUSIONS:
Inhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Agitação Psicomotora
/
Esquizofrenia
/
Antipsicóticos
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Loxapina
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Br J Psychiatry
Ano de publicação:
2011
Tipo de documento:
Article
País de afiliação:
Estados Unidos