NCT03513549

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

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

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Agitation,Psychomotor

Interventions

Type	Name	Description
DRUG	Loxapine 10 MG

Timeline

• Start date: 2014-11-04
• Primary completion: 2027-02-01
• Completion: 2027-09-01
• First posted: 2018-05-01
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study