NCT00508157终止4 期
A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2007年11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
- 终止
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
研究概览
简要总结
258 patients who have been treated for at least 3 months with oral olanzapine, risperidone or quetiapine in the treatment of schizophrenia and currently presenting with metabolic syndrome, will be randomized to: i) aripiprazole for 16 weeks, with flexible dosing within a range of 10 to 30 mg once daily (QD); or ii) continue for 16 weeks on the same atypical antipsychotic treatment prior to the study enrollment.
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
- •with schizophrenia being treated with olanzapine, risperidone, or quetiapine for at least 3 months
- •with diagnosis of metabolic syndrome
- •not treated for 1 of the parameters of metabolic syndrome
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
干预措施: Aripiprazole (Drug)
B
Active Comparator
干预措施: Continued Antipsychotic (Risperidone or Quetiapine or Olanzapine) (Drug)
结局指标
主要结局
Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
时间窗: Baseline, Week 16
Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol.
次要结局
- Number of Participants Remaining on Metabolic Syndrome at Week 16(Week 16)
- Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16(Baseline, Week 4, Week 8, Week 12, Week 16)
- Mean Change From Baseline for Fasting Glucose Levels Through Week 16(Baseline, Week 4, Week 8, Week 12, Week 16)
- Mean Change From Baseline in Body Weight Through Week 16(Baseline, Week 4, Week 8, Week 12, Week 16)
- Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16(Baseline, Week 4, Week 8, Week 12, Week 16)
- Median Change From Baseline in Body Mass Index (BMI) Through Week 16(Baseline, Week 4, Week 8, Week 12, Week 16)
- Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16(Baseline, Week 4, Week 8,Week 12, Week 16)
- Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16(Baseline, Week 4, Week 8, Week 12, Week 16)
研究者
研究点 (1)
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