Observational, Non-interventional Registry to Assess Medication Usage Patterns in Clinical Routine Practice, in Subjects Receiving Antipsychotic Treatment With Risperidone Long Acting Injectable (Gluteal or Deltoid) or Oral Antipsychotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,085
- 主要终点
- prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments
研究概览
简要总结
International Observational Registry on Schizophrenia
详细描述
This is an observational, non-interventional registry designed to assess medication usage patterns and to explore, in clinical routine practice, long-term outcomes and relevant factors for patient adherence to treatment, in patients receiving antipsychotic treatment with risperidone long-acting injectable (RLAI) or oral antipsychotics. Six month retrospective data and 1 year prospective data will be collected. According to label
研究设计
- 研究类型
- Observational
- 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 must satisfy the following criteria to be eligible for documentation in this non-interventional study: Diagnosis of schizophrenia as well as 6 months of retrospective clinical records
- •Newly initiated on or switched to RLAI or an oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago
- •Signed informed consent (either signed by the patient or his/her legal representative) is available at the beginning of documentation
- •any schizophrenic patient (including those for whom a legal representative must sign consent) can be involved in the study
排除标准
- •Established treatment refractory schizophrenia, defined as treatment failures with adequate trials (adequate as judged by the treating physician) of more than 2 second generation (atypical) antipsychotics and/or clozapine
- •History of neuroleptic malignant syndrome
研究组 & 干预措施
antipsychotic treatment
Risperidone Long-Acting injectable or oral antipsychotics According to label
干预措施: Risperidone Long-Acting injectable or oral antipsychotics (Drug)
结局指标
主要结局
prospectively assess medication usage patterns under routine clinical practice related to initiation of treatment with risperidone RLAI and oral antipsychotic treatments
时间窗: baseline, month 1, 3, 6, 9 & 12
次要结局
- Long-term safety data of RLAI (25, 37.5 or 50 mg every 2 weeks) and oral antipsychotics will be collected(1, 3, 6, 9, 12 month)
- To collect 6-month retrospective and 1-year prospective data to allow the exploration of treatment outcomes including hospitalizations and rehospitalizations, with RLAI and oral antipsychotics, in relation to previous treatments(1, 3, 6, 9, 12 month)
- To evaluate the reasons for initiation and/or discontinuation of new antipsychotic medications, including patient satisfaction with treatment(1, 3, 6, 9, 12 month)
- To explore relevant factors for patient adherence to treatment(1, 3, 6, 9, 12 month)
- To document clinical effectiveness and functionality of patients on RLAI and oral antipsychotics in daily clinical practice (as measured by the Global Assessment of Functioning [GAF] scale(1, 3, 6, 9, 12 month)