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 Details — Status: Recruiting

Administrative data

• NCT number: NCT03513549
• Other study ID #: TV571-CNS-40036
• Status: Recruiting
• Start date: November 4, 2014
• Est. completion date: March 2022

Study information

• Verified date: October 2020
• Source: Alexza Pharmaceuticals, Inc.
• Contact: Tatjana Naranda, PhD
• Phone: 650-944-7523
• Email: tnaranda[@]alexza.com
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: March 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Agitation,Psychomotor
• Psychomotor Agitation
• Schizophrenia

Intervention

Drug:
• Loxapine 10 MG

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.	Pharmaceutical Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory objective - patient treatment satisfaction	The exploratory objective of the study is to assess patient perception of effectiveness (ranging from extremely dissatisfied to extremely satisfied), convenience (ranging from extremely inconvenient to extremely convenient), and overall satisfaction (ranging from extremely dissatisfied to extremely satisfied) using a modified Treatment Satisfaction Questionnaire for Medication (TSQM) after administration of ADASUVE treatment in real-world clinical settings. The TSQM is a modified version of the original TSQM version 1.4, a widely used generic measure to assess treatment satisfaction with medication. Scores range from 0 to 100, with higher scores representing higher satisfaction.	24 hours
Primary	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.	24 hours
Secondary	Patient demographics	The secondary measure of this study is patient characteristics, including demographic characteristics, after administration of ADASUVE treatment in real-world clinical settings.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours