NCT00325689已完成4 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
Otsuka Pharmaceutical Development & Commercialization, Inc.47 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 47
- 主要终点
- Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
研究概览
简要总结
A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.
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
- Double (Participant, Investigator)
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
- •Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
- •Stable symptoms and dose of Quetiapine or Risperidone
排除标准
- •First diagnosis in the past year
- •Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
研究组 & 干预措施
Quetiapine or Risperidone + Aripiprazole
Active Comparator
干预措施: Quetiapine or Risperidone + Aripiprazole (Drug)
Quetiapine or Risperidone + placebo
Placebo Comparator
干预措施: Quetiapine or Risperidone + placebo (Drug)
结局指标
主要结局
Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint
时间窗: (Week 16) or at time of discontinuation
次要结局
- Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S)(at endpoint (Week 16))
研究者
研究点 (47)
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