Maintenance of Clinical Response With Risperidone Long Acting Injectable (R-LAI) in Patients With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 347
- 主要终点
- Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score
研究概览
简要总结
The purpose of this study is to assess the maintenance of antipsychotic efficacy and safety of risperidone long-acting injectable (RLAI) in patients with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) or schizoaffective (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder) disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy. The secondary aim is to investigate prospectively (a study that starts with the present condition of a population of individuals and follows them into the future) the prevalence of patients who met standardized remission criteria (according to Andreasen et al. criteria) and the psychopathological, psychosocial and subjective predictors of achieving remission.
详细描述
This is a prospective, open-label, (all people know the identity of the intervention), single-arm study conducted at 47 sites in Italy between January 2005 and April 2007. Approximately 338 patients with schizophrenia or schizoaffective disorder who were receiving treatment with any antipsychotic medication and who required a long-term antipsychotic therapy will be switched directly to RLAI without an oral risperidone run-in (the elapsed time before a trial is started when no treatment is given to patients in the study). They will be considered either not optimally treated or symptom-free. Patients will be either not hospitalized or living in residential structures at the time of the enrollment as well as throughout the study. The maximum duration of study participation will be 52 weeks. Patient safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- •Required long-term antipsychotic therapy at the time of recruitment
- •Symptomatically stable and taking the same dose of antipsychotic agents for at least one month before the baseline visit (considered stable if there have been no appreciable change in symptoms over the previous month, regardless of the severity of their symptoms)
- •Patients or their legal representatives provided their written informed consent prior to enrollment in the study
排除标准
- •Patients who had received clozapine during the previous 3 months
- •Participated in an investigational drug trial in the previous 30 days
- •Previously been shown to be either intolerant or non-responsive to risperidone therapy
- •Presence of a serious unstable medical condition, such as a history or current symptoms of tardive dyskinesia or a history of neuroleptic malignant syndrome
- •Pregnant or breast-feeding; female patients of childbearing potential not using adequate contraception
研究组 & 干预措施
Risperidone Long-acting Injectable (LAI)
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
干预措施: Risperidone Long-acting Injectable (LAI) 25 mg (Drug)
Risperidone Long-acting Injectable (LAI)
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
干预措施: Risperidone LAI 37.5 mg (Drug)
Risperidone Long-acting Injectable (LAI)
Risperidone LAI will be administered in dosages of 25, 37.5, and 50 mg.
干预措施: Risperidone LAI 50 mg (Drug)
结局指标
主要结局
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total and subscales score
时间窗: Baseline and after 4, 12, 26, 38 and 52 weeks
Maintenance= Symptom severity assessed with PANSS scale vs baseline (Total, positive, negative, general psychopathology and cognitive cluster score); Remission= percentage of patients with 8 specific items PANSS simultaneously scoring \<= 3 for at least 6 months
次要结局
- Clinical Global Impression-Severity (CGI-S) scale(Baseline)
- Change from Baseline in Clinical Global Impression-Change (CGI-C) scale(Baseline and after 4, 12, 26, 38 and 52 weeks)
- Change from Baseline in Global Assessment of Functioning (GAF)(Baseline and after 4, 12, 26, 38 and 52 weeks)
- Change from Baseline in Drug Attitude Inventory (DAI 30)(Baseline and after 4, 12, 26, 38 and 52 weeks)
- The number of patients who experience adverse events as a measure of safety and tolerability.(Baseline and after 4, 12, 26, 38 and 52 weeks)