PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,064
- 主要终点
- Primary treatment duration and time to treatment discontinuation
研究概览
简要总结
The purpose of this non-interventional, observational and international registry study is to document the prescribing patterns in daily clinical practice and to assess long term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting.
详细描述
PILAR is a non-interventional, observational, international registry on the use of oral antipsychotics in a naturalistic setting in patients with schizophrenia. Patients initiating a new oral antipsychotic treatment are candidates for documentation in this registry. All patients should be treated according to local labeling specifications. The overall study objective is to document prescribing patterns in daily clinical practice and to assess long-term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting. The primary objective is to prospectively document over one year treatment outcomes and healthcare utilization data that will enable a cost-effectiveness analysis of paliperidone ER compared to other oral antipsychotic treatments. Additional objectives are to retrospectively collect data over one year, which will allow the evaluation of treatment outcomes before and after treatment initiation with paliperidone ER or other oral antipsychotics. Evaluation of Adverse Drug Reactions (ADR) and Serious Adverse Drug Reactions (SADR) for the retrospective period, and Adverse Events (AE) and Serious Adverse Events (SAE) during the prospective period will be performed and reported. Dosing and administration of all treatments should be prescribed at the physician's discretion, and should be based on approved local labels. Dose adjustments or medication changes should be made by the treating physician based on clinical judgment and usual practice. Subjects should receive their medication according to usual care in their treatment setting, and no study drug will be provided. The documentation of the treatment will last one year.
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
- •Diagnosis of schizophrenia
- •Switch to or start on paliperidone ER or another oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago
- •Signed informed consent is available at the beginning of documentation
- •Able and willing to fill-out self-administered questionnaires
排除标准
- •Established treatment-refractory schizophrenia
- •History of neuroleptic malignant syndrome
结局指标
主要结局
Primary treatment duration and time to treatment discontinuation
时间窗: Prospective 1-year observation period
Primary treatment duration is defined as the time interval (in days) between baseline and stop of the new antipsychotic treatment started at baseline.
次要结局
- Deterioration of the psychotic condition(at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation)
- The prospectively documented treatment outcomes also include overall severity of symptoms, personal and social performance, healthcare utilization and health related quality of life and quality of sleep.(12 months)
- Use of concomitant medications(during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation)
