NCT01734278已完成不适用
An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England
Professor Saad Shakir1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The incidence of selected identified risks of asenapine in the mental health care trust setting
研究概览
简要总结
The purpose of this observational study is to evaluate the use and short term safety of Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the manufacturer of Sycrest.
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 for whom a study questionnaire containing useful information has been returned
排除标准
- •Patients who do not provide consent
- •Patients within selected institutions (for example prisons)
- •Patients who commenced treatment between date of market launch (to be confirmed) and study start
- •Enrolled patients for whom both the baseline and 12-week questionnaires are returned blank (contain no clinical information)
- •Enrolled patients for whom the psychiatrist, designated member of clinical care team, or study facilitator from the DSRU reports that the patient did not take or was never prescribed asenapine
- •Enrolled patients for whom there is evidence to suggest duplication of patients
- •Enrolled patients for whom informed written or verbal notification is received by DSRU indicating that they no longer wish to participate at any stage of the study
结局指标
主要结局
The incidence of selected identified risks of asenapine in the mental health care trust setting
时间窗: 12 weeks after asenapine is first prescribed
次要结局
未报告次要终点
研究者
Professor Saad Shakir
Director
Drug Safety Research Unit, Southampton, UK
研究点 (1)
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