A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness

Hoffmann-La Roche0 个研究点目标入组 1,433 人开始时间: 2011年2月最近更新: 2016年11月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 1,433
主要终点: Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.

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

•Adult patients, >/= 18 years of age
•Diagnosis of schizophrenia according to Diagnostic and Statistical Manual for Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) or International Classification of Diseases, 10th revision (ICD-10)
•Caregivers:
•Age >/= 18 years
•Family member or friend of the patient, who spends at least 4 hours a week with the patient

排除标准

•Acute psychotic exacerbation in the 3 months prior to the baseline observation (e.g. hospitalization or increased psychiatric care in order to prevent hospitalization)
•Enrolled in an interventional study at the baseline observation

结局指标

主要结局

Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores

时间窗: from baseline to Month 24

次要结局

Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline(at screening (approximately 18 months))
Medical resource utilization/costs(24 months)
Duration/severity of symptoms of schizophrenia according to Personal Social Performance Scale (PSP) / Health Related Quality of Life (HRQoL) questionnaire(24 months)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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