Rapid acute treatment of agitation in individuals with schizophrenia: multicentre, randomised, placebo-controlled study of inhaled loxapine

Author:

Lesem Michael D.,Tran-Johnson Tram K.,Riesenberg Robert A.,Feifel David,Allen Michael H.,Fishman Robert,Spyker Daniel A.,Kehne John H.,Cassella James V.

Abstract

BackgroundThere is a need for a rapid-acting, non-injection, acute treatment for agitation.AimsTo evaluate inhaled loxapine for acute treatment of agitation in schizophrenia.MethodThis 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.ResultsInhaled 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 10mg 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.ConclusionsInhaled loxapine provided a rapid, well-tolerated acute treatment for agitation in people with schizophrenia.

Publisher

Royal College of Psychiatrists

Subject

Psychiatry and Mental health

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