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Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

Agitation,Psychomotor Clinical Trial

Official title:
A Postmarketing Observational Study to Evaluate the Safety of ADASUVE® (STACCATO® Loxapine for Inhalation) in Patients With Agitation Associated With Schizophrenia or Bipolar I Disorder

Clinical Trial Summary

This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.

Clinical Trial Description

This is a multicenter, prospective, observational study conducted to evaluate the safety of ADASUVE treatment when used in real-world clinical setting in patients with agitation associated with schizophrenia or bipolar I disorder. The primary objective of the study is to assess the safety of ADASUVE treatment in real-world clinical settings. The secondary objective of the study is to describe the characteristics of patients, including demographic and baseline characteristics, after administration of ADASUVE treatment in real-world clinical settings. The study population will consist of a non-randomized cohort of approximately 10000 adult men and women who have agitation associated with schizophrenia or bipolar I disorder (naïve and non-naïve to ADASUVE treatment). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03513549
Study type Observational
Source Alexza Pharmaceuticals, Inc.
Contact Tatjana Naranda, PhD
Phone 650-944-7523
Email tnaranda@alexza.com
Status Recruiting
Phase
Start date November 4, 2014
Completion date March 2022
View Details
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