Abstract | OBJECTIVE: The present study evaluated inhaled loxapine for the acute treatment of agitation in patients with bipolar I disorder. METHODS: A Phase 3, randomized, double blind, placebo-controlled, parallel group inpatient study was performed at 17 psychiatric research facilities. Agitated patients (N=314) with bipolar I disorder (manic or mixed episodes) were randomized (1:1:1) to inhaled loxapine 5 mg or 10 mg, or inhaled placebo using the Staccato® system. Following baseline assessments, patients received Dose 1 and were evaluated for 24 hours. If required, up to two additional doses of study drug and/or lorazepam rescue medication were given. The primary efficacy endpoint was change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score two hours after Dose 1. The key secondary endpoint was the Clinical Global Impression-Improvement score at two hours after Dose 1. Additional endpoints included the changes from baseline in the PANSS-EC from 10 min through 24 hours after Dose 1. Safety was assessed by adverse events, vital signs, physical examinations, and laboratory tests. RESULTS: For the primary and key secondary endpoints, both doses of inhaled loxapine significantly reduced agitation compared with placebo. Reduced agitation, as reflected in PANSS-EC score, was evident 10 min after Dose 1 with both 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 ( dysgeusia was reported in 17% of patients receiving active drug versus 6% receiving placebo). CONCLUSIONS: Inhaled loxapine provided a rapid, non-injection, well-tolerated acute treatment for agitation in patients with bipolar I disorder.
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Authors | Joseph Kwentus, Robert A Riesenberg, Morteza Marandi, Raymond A Manning, Michael H Allen, Robert S Fishman, Daniel A Spyker, John H Kehne, James V Cassella |
Journal | Bipolar disorders
(Bipolar Disord)
Vol. 14
Issue 1
Pg. 31-40
(Feb 2012)
ISSN: 1399-5618 [Electronic] Denmark |
PMID | 22329470
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Copyright | © 2012 John Wiley and Sons A/S. |
Chemical References |
- Antipsychotic Agents
- Loxapine
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Topics |
- Administration, Inhalation
- Adult
- Antipsychotic Agents
(administration & dosage)
- Bipolar Disorder
(complications, drug therapy)
- Double-Blind Method
- Female
- Humans
- Loxapine
(administration & dosage)
- Male
- Middle Aged
- Psychomotor Agitation
(drug therapy, etiology)
- Treatment Outcome
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