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This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.
Full 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).
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Inclusion criteria
Patients may be included in the study if they meet all of the following criteria:
Exclusion criteria
There are no exclusion criteria for this study.
10,000 participants in 1 patient group
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Central trial contact
Tatjana Naranda, PhD
Data sourced from clinicaltrials.gov
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