Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,292
- 试验地点
- 4
- 主要终点
- Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
研究概览
简要总结
The aim of the study is to describe patient characteristics (demographic and clinical) and the patterns of use of Quetiapine XR in patients receiving the drug for the first time in real-life practice regardless the final diagnosis.
详细描述
Description of the use of Quetiapine Extended Release (XR) in real-life practice in France
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New patients treated with Xeroquel XR
- •Patients aged 18 years and over
- •Diagnosis of bipolar disorder or schizophrenia according to DSM-IV criteria
排除标准
- •Patient included in a therapeutic trial (Huriet-Serusclat Act)
- •Patient refusing to participate in the study
- •Pregnant women
结局指标
主要结局
Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
时间窗: At inclusion
Variables related with how the drug is prescribed and used by the patient \[doses in mg/day, titration (yes/no), time of administration (morning/middle of the day/afternoon/evening), concomitant treatments\] are going to be described.
Description of patient's socio-demographics profile.
时间窗: At inclusion
Age, gender, educational and professional status, co-habitation are going to be described.
Descriptive analysis of medical history.
时间窗: At inclusion
Diagnosis, family history of psychiatric disorders, number of suicidal attempts within the last 12 months, co-morbidities, treatments received during the last 12 months, laboratory and exam data will be included in the description.
Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).
时间窗: At inclusion
The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness. The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients.
次要结局
- Descriptive analysis of all adverse events.(From baseline to 12 months)
- Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.(From baseline to 12 months)
- Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.(From baseline to 12 months)
- Descriptive analysis of the treatment changes: drug switches.(From baseline to 12 months)
- Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.(From baseline to 12 months)
- Change in Body Mass Index (BMI).(From baseline to 12 months)
- Laboratory tests- cholesterol.(From baseline to 12 months)
- Relapses (only for the schizophrenia subpopulation).(From baseline to 12 months)
- Laboratory tests- glycemia.(From baseline to 12 months)