Staccato Loxapine in Agitated Patients With Bipolar Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Disorder

In brief

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

Key facts

Study ID

NCT00721955

Run by

Alexza Pharmaceuticals, Inc.

People needed

314

Starts

2008-07-01

Expected to finish

2008-10-01

Last updated by the study team

2017-07-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Synergy Escondido — Escondido, California, United States
• Collaborative NeuroScience Network, Inc. — Garden Grove, California, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• FutureSearch Trials — Austin, Texas, United States
• Claghorn-Lesem Research Clinic — Houston, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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