A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- Number of patients with symptomatic relapse
研究概览
简要总结
The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.
详细描述
This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
- •Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate
- •Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.
排除标准
- •Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation
- •Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.
研究组 & 干预措施
001
paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
干预措施: paliperidone palmitate (Drug)
结局指标
主要结局
Number of patients with symptomatic relapse
时间窗: Up to 12 months
次要结局
- Clinical effectiveness and social outcomes as measured by HoNOS.(Up to 12 months)
- Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.(Up to 12 months)
- Clinical effectiveness and social outcomes as measured by PSP.(Up to 12 months)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 12 months)
- Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF(Up to 12 months)