Schizophrenia Treatment Acceptance Response Trial: a 20-week, Open-label, Multicenter, Randomized Study Comparing the Effect of the "GAIN Acceptance Approach Verses the "Approach-as-usual" in Supporting Patient Acceptance of Long-acting Risperidone (Risperdal� CONSTA�) in Adults With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Janssen, LP
- 入组人数
- 650
- 主要终点
- After 12 weeks of treatment, the percentage of patients accepting long-acting risperidone injection switched using the "Gain Acceptance Approach" compared with those switched using the "approach as usual"
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
Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. Patients will continue their treatment 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 (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia
- •long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study
- •stable with respect to disease symptoms and other medical conditions
- •if female, using birth control.
排除标准
- •At risk to self or others
- •use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days
- •considered to be resistant to treatment
- •pregnant or breast-feeding
- •not using birth control.
结局指标
主要结局
After 12 weeks of treatment, the percentage of patients accepting long-acting risperidone injection switched using the "Gain Acceptance Approach" compared with those switched using the "approach as usual"
次要结局
- Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C) to measure disease severity; Patient Attitude/Satisfaction scale and Clinician Attitude/Satisfaction scale after 12 weeks of treatment, measuring satisfaction
