The SOURCE Study: Schizophrenia Outcomes-utilization, Relapse, and Clinical Evaluation: a Prospective 2-year Observational Study of Patients With Schizophrenia Who Initiate Treatment With Injectable Risperidone Long-acting Microspheres (RISPERDAL CONSTA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Janssen, LP
- 入组人数
- 532
- 主要终点
- Change from baseline to 24 months in Personal and Social Performance (PSP) scores
研究概览
简要总结
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.
详细描述
This is a 2-year, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), multi-center (at multiple sites), longitudinal (study that involves repeated observations of the same outcomes in the same people over long periods of time), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) in adults with schizophrenia (mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness). Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injection (an antipsychotic medication) and meeting all the study criteria will be enrolled in the study. They will receive a dose of 25, 37.5 or 50 mg of risperidone every 2 weeks by intramuscular injection, and continue their treatment for schizophrenia according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (eg, emergency room visits and hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study duration of 2 years.
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 had schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated) that met disease diagnostic criteria as defined in Diagnostic and Statistical Manual of Mental Disorders IV ([DSM-IV]
- •Requiring new treatment with long-acting risperidone injectable
- •Patients were cooperative, reliable, and able to complete all aspects of the protocol
排除标准
- •Use of an investigational drug in the past 30 days
- •At risk to self or others
研究组 & 干预措施
Patients with schizophrenia
Long-acting injectable of risperidone given as per the prescription from the prescribing physician (Observational study).
干预措施: risperidone (RISPERDAL CONSTA) (Drug)
结局指标
主要结局
Change from baseline to 24 months in Personal and Social Performance (PSP) scores
时间窗: Baseline to 24 months
The PSP Scale is completed by the physician. PSP is a rating of a patient's level of functioning during the past month in 4 areas: (a) socially useful activities (including work and study); (b) personal and social relationships; (c) self-care; and (d) disturbing and aggressive behaviors. Scores range from 1 to 100. (1= Lack of autonomy in basic functioning and 100 = Excellent functioning in all 4 main areas).
Change from baseline to 24 months in Strauss-Carpenter Levels of Function (LOF) scores
时间窗: Baseline to 24 months
The Strauss-Carpenter LOF is completed by the physician. It consists of 9 items that can be grouped into 4 subscales: symptoms (absence of symptoms and recent hospitalizations), social contacts (frequency and quality of social contacts), work (quantity and quality of useful work), and function (ability to meet basic needs, fullness of life, and overall level of function). Each item is rated on a scale of 0 (worst functioning) to 4 (best functioning).
Change from baseline to 24 months in Clinical Global Impression of Severity (CGI-S) scores
时间窗: Baseline (Month 0) to 24 months
The CGI-S is a 7-point scale ranging from 1 to 7 (normal, not at all ill to among the most severely ill patients), which measures disease severity in psychiatric patients. The scale is completed by physician.
Clinical Global Impression of Change (CGI-C) scores during 24 months
时间窗: 24 months
The CGI-C is a 7-point scale ranging from 1 to 7 (very much improved to very much worse), which is used to rate the change in the patient's illness compared to baseline. The scale assesses the patient's improvement over time. The scale is completed by physician.
Change from baseline to 24 months in Global Assessment of Function (GAF) scores
时间窗: Baseline to 24 months
GAF is completed by the physician. GAF is a single item rating of the patient's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness. Respondents are asked to rate the subject's lowest level of functioning in the last week. GAF scores range from 0 to 100. (0 = Inadequate information, 1 = Persistent danger of severely hurting self or others and 100 = Superior functioning in a wide range of activities).
次要结局
- Change from baseline to 24 months in Quality of Life Assessment: Medical Outcomes Survey Short Form (SF-36) scores(Baseline to 24 months)
- Change from baseline to 24 months in patient satisfaction with antipsychotic medication(Baseline to 24 months)
- Change from baseline to 24 months in healthcare resource utilization(Baseline to 24 months)