NCT00067444已完成3 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Fixed Dose Study Evaluating the Efficacy and Safety of Paroxetine CR in Elderly Outpatients Diagnosed With Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 560
- 试验地点
- 47
- 主要终点
- Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.
研究概览
简要总结
Major Depressive Disorder (MDD) Study in Elderly Outpatients
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
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder (MDD).
- •Current major depressive episode at screen at least 2 months duration.
- •Must be at least 60 years of age.
排除标准
- •Patients with a primary diagnosis other than MDD.
- •Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia.
- •Patients with a history of brief depressive episodes lasting less than 8 weeks.
- •Patients receiving formal psychotherapy within 12 weeks of study.
- •Patients who are suicidal.
- •Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening.
- •Patients with a history or seizure disorders.
结局指标
主要结局
Change from baseline to the week 10 last observation carried forward endpoint in the 17-item HAM-D total score.
时间窗: 10 Weeks
次要结局
- Mean change from baseline in HAM-D item 1; Mean change from baseline in the CGI severity of illness score at study endpoint; Percentage of patients with HAM-D total score less than or equal to 7.(10 Weeks)
研究者
研究点 (47)
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