Staccato Loxapine in Agitated Patients With Bipolar Disorder

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in bipolar 1 disorder patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alexza Pharmaceuticals, Inc.
• Treatments: Loxapine

Criteria

Inclusion Criteria:

• Male and female adult patients with bipolar 1 disorder and acute agitation

Exclusion Criteria:

• Agitation caused primarily by acute intoxication

• History of drug or alcohol dependence

• Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration