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

Alexza Pharmaceuticals, Inc.10,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Agitation,Psychomotor

Interventions

Loxapine 10 MGDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 emergency setting or in a psychiatric inpatient setting. (Note: Patients with a prior history of treatment with ADASUVE may also be included in the study.) 3. The patient (or caregiver or legally authorized representative) is willing and able to provide written informed consent (and assent, where applicable) after administration of ADASUVE treatment. Exclusion Criteria: There are no exclusion criteria for this study.

Locations (1)

Pharmaceutical Research Associates, Inc

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

Evaluating frequency and nature of adverse events, serious adverse events and respiratory adverse events of special interest (AESIs) after administration of ADASUVE treatment in real-world clinical settings

Safety will be assessed by evaluating adverse events, serious adverse events, and respiratory AESIs within the study follow-up period after administration of ADASUVE treatment in real-world clinical settings.

Time frame: 24 hours

Secondary Outcomes

Patient demographics

The secondary measure of this study is patient characteristics, including demographic characteristics, after administration of ADASUVE treatment in real-world clinical settings.

Time frame: 24 hours

Patient baseline characteristics - medical history

The secondary measure of this study is patient characteristics, including baseline characteristic of medical history, after administration of ADASUVE treatment in real-world clinical settings.

Time frame: 24 hours

Patient baseline characteristics - prior medications

The secondary measure of this study is patient characteristics, including baseline characteristic of prior medications, after administration of ADASUVE treatment in real-world clinical settings.

Time frame: 24 hours

Data from ClinicalTrials.gov

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