OASIS: Observational Study of LAIs In Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 1
- 主要终点
- Schizophrenia disease history
研究概览
简要总结
The objectives of this study are to describe characteristics, treatment patterns, and outcomes of patients with schizophrenia newly initiated on 1 of 4 FDA-approved atypical Long Acting Injectable (LAI) antipsychotics (ABILIFY MAINTENA®, ARISTADA®, INVEGA SUSTENNA® or RISPERDAL CONSTA®)
详细描述
This is a non-interventional, prospective, multi-center observational cohort study. Patients at behavioral health clinics will be enrolled and evaluated by health care professionals (e.g., psychiatrists) according to the standard of care. All patients will be followed for approximately 12 months from their enrollment visit.
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
- •Must be able to speak, read and understand English
- •Diagnosis of schizophrenia as defined by the treating clinician
- •Newly initiating treatment with 1 of 4 atypical Long Acting Injectables (LAIs): Abilify Maintena, Aristada, Invega Sustenna, or Risperdal Consta)
- •Additional criteria may apply
排除标准
- •Currently participating or planning to participate in an interventional clinical study, or has completed participation in an interventional clinical study within 30 days before enrollment
- •In the opinion of the investigator, is currently an imminent danger to himself/herself. [Note: A prior history of suicidal ideation or suicidal attempt is not exclusionary.]
- •Additional criteria may apply
结局指标
主要结局
Schizophrenia disease history
时间窗: Baseline
Including time (years) since diagnosis as assessed from clinical history
Number of LAI injections
时间窗: Up to 12 months
Average number of injections during treatment period
Number of comorbid conditions at baseline
时间窗: Baseline
Assessed from clinical history
Changes in comorbid conditions
时间窗: Up to 12 months
The percent of patients experiencing each comorbid condition will be assessed at follow-up visits
Number of patients switching or discontinuing LAI treatment
时间窗: Up to 12 months
次要结局
未报告次要终点