NCT00232687已完成4 期
A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone
Otsuka Pharmaceutical Development & Commercialization, Inc.73 个研究点 分布在 8 个国家目标入组 450 人开始时间: 2005年6月1日最近更新:
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
- 450
- 试验地点
- 73
- 主要终点
- Proportion of patients who discontinue because of Adverse Events
研究概览
简要总结
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
- •Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
- •Men and women, aged 18 - 65 years
排除标准
- •Patients who are at risk for committing suicide
- •Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
- •Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
- •Treatment-resistant to antipsychotic medication
研究组 & 干预措施
A1
Active Comparator
干预措施: Aripiprazole (Drug)
A2
Active Comparator
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Proportion of patients who discontinue because of Adverse Events
Proportion of patients who discontinue because of Adverse Events
时间窗: Up to 22 months
次要结局
- Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint
- Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint(Up to 22 months)
研究者
研究点 (73)
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