Clinical trial NCT03513549: Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Agitation,Psychomotor
Keywords: Agitation
Schizophrenia
Bipolar I disorder
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2018-05-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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), as determined by the treating health care provider, and who meet the eligibility criteria.

Brief 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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 24 hours
Secondary outcomes:
measure: Patient demographics
timeFrame: 24 hours
measure: Patient baseline characteristics - medical history
timeFrame: 24 hours
measure: Patient baseline characteristics - prior medications
timeFrame: 24 hours
Other outcomes:
measure: Exploratory objective - patient treatment satisfaction
timeFrame: 24 hours
Locations:
city: Raleigh
country: United States
facility: Pharmaceutical Research Associates, Inc
state: North Carolina
Study officials:
References: