NCT01746134已完成不适用
A Prospective, Non-Interventional Registry of Diverse Patients With Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course of Disease, Treatments, and Burden of Illness
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 557
- 主要终点
- Positive and Negative Symptoms of Schizophrenia (PANSS)
研究概览
简要总结
This study is a disease-based registry designed to follow patients with a DSM-IV-TR (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care settings for up to 5 years. The registry seeks to describe the course of disease in schizophrenia, including cognitive function and negative symptoms, its treatment, and its burden of disease for participants, caregivers, clinicians, and society as a whole.
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
- •DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
- •Participants presenting with the normal course of care in usual treatment settings
- •Able to read and speak English
- •Able and willing to provide informed consent
- •Able and willing to comply with the study protocol
排除标准
- •Participants enrolled as subjects in clinical trials at registry enrollment
- •Participants anticipating they will be unable to participate in regularly scheduled assessments as per protocol
结局指标
主要结局
Positive and Negative Symptoms of Schizophrenia (PANSS)
时间窗: up to 5 years
Clinical Global Impression Schizophrenia Scale (CGI-SCH)
时间窗: up to 5 years
Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test)
时间窗: up to 5 years
次要结局
- Negative Symptom Assessment Scale (NSA4)(up to 5 years)
- Pharmacologic/behavioural treatments used in usual care settings: intervention(up to 5 years)
- Pharmacologic/behavioural treatments used in usual care settings: dose(up to 5 years)
- Pharmacologic/behavioural treatments used in usual care settings: duration(up to 5 years)
- Personal and Social Performance (PSP)(up to 5 years)
- Schizophrenia Quality of Life Scale (SQLS)(up to 5 years)
- Schizophrenia Caregiver Questionnaire(up to 5 years)
- Maslach Burnout Inventory (MBI)(up to 5 years)
研究者
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