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

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.

• Authors: Michael D Lesem, Tram K Tran-Johnson, Robert A Riesenberg, David Feifel, Michael H Allen, Robert Fishman, Daniel A Spyker, John H Kehne, James V Cassella
• Journal: The British journal of psychiatry : the journal of mental science (Br J Psychiatry) Vol. 198 Issue 1 Pg. 51-8 (Jan 2011) ISSN: 1472-1465 [Electronic] England
• PMID: 21200077 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Placebos
• Loxapine

Topics

• Acute Disease
• Administration, Inhalation
• Adolescent
• Adult
• Aged
• Antipsychotic Agents (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Drug Delivery Systems
• Female
• Humans
• Kaplan-Meier Estimate
• Loxapine (administration & dosage, adverse effects)
• Male
• Middle Aged
• Placebos
• Psychiatric Status Rating Scales
• Psychomotor Agitation (drug therapy)
• Schizophrenia (drug therapy)
• Time Factors
• Treatment Outcome
• Young Adult