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

Last updated: October 13, 2020
Sponsor: Alexza Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Manic Disorders

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT03513549
TV571-CNS-40036
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients may be included in the study if they meet all of the following criteria:

  1. The patient is a man or woman who is 18 years of age or older at time of enrollment.

  2. The patient is receiving ADASUVE for agitation in a medical or psychiatric emergencysetting or in a psychiatric inpatient setting. (Note: Patients with a prior history oftreatment with ADASUVE may also be included in the study.)

  3. The patient (or caregiver or legally authorized representative) is willing and able toprovide written informed consent (and assent, where applicable) after administrationof ADASUVE treatment.

Exclusion

Exclusion Criteria: There are no exclusion criteria for this study.

Study Design

Total Participants: 10000
Study Start date:
November 04, 2014
Estimated Completion Date:
March 31, 2022

Study 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).

Connect with a study center

  • Pharmaceutical Research Associates, Inc

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

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