A 12-Week Open-Label Trial of Once-Weekly Fluoxetine for the Treatment of Depression in Patients With End-Stage Renal Disease
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
研究概览
简要总结
The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.
详细描述
Once-weekly Prozac is a psychiatric medicine, approved by the FDA for the use in treatment of psychiatric disorders. This study will test whether once-weekly Prozac leads to reduced symptoms of depression. Patients requiring dialysis often report symptoms of depression either due to the presence of major depression, a relatively common psychiatric disorder, or due to depression secondary to kidney failure.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic renal failure and end stage renal disease
- •Ongoing need for regular dialysis treatment
- •Diagnosis of depression based on DSMIV
- •Age tween 19-65 years
排除标准
- •Inability to provide informed consent
- •Medically or psychiatrically unstable, as defined by requiring inpatient treatment
- •Pregnancy, nursing or refusal to use a reliable method of birth control in women
- •Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine
结局指标
主要结局
Determine the efficacy and tolerability of once-weekly fluoxetine in patients with End Stage Renal Disorder who have been diagnosed with depression
时间窗: Patients will come in for once weekly visits for 12 weeks
次要结局
未报告次要终点