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
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
This postmarketing observational study will evaluate the safety of ADASUVE® in treating patients with agitation associated with schizophrenia or bipolar I disorder.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be included in the study if they meet all of the following criteria:
- •The patient is a man or woman who is 18 years of age or older at time of enrollment.
- •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.)
- •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.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Loxapine 10 MG
ADASUVE (loxapine) inhalation powder in a 10-milligram (mg) single-use oral inhaler. One dose in a 24-hour period.
干预措施: Loxapine 10 MG (Drug)
结局指标
主要结局
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
时间窗: 24 hours
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.
次要结局
- Patient demographics(24 hours)
- Patient baseline characteristics - medical history(24 hours)
- Patient baseline characteristics - prior medications(24 hours)