NCT00330616已完成2 期
Clinical Evaluation of Bupropion SR (323U66)in Patients With Depression - Investigation in Elderly Patients With Depression
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
研究概览
简要总结
This is a study to obtain clinical experience of 323U66 SR for elderly patients with depression in repeat-dose of 323U66 SR up to 300mg/day, and to conduct exploratory investigation on safety, efficacy and pharmacokinetics profile in elderly patients with depression.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 8
时间窗: Baseline and Week 8
The Hamilton Rating Scale for Depression (HAM D) contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM D score range from 0 (not ill) to 53 (severely ill).
次要结局
- Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4(Baseline and Week 4)
- Percentage Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)Total Score at Week 8(Baseline and Week 8)
- Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4(Week 4)
- Percentage of Responders Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8(Week 8)
- Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 4(Week 4)
- Percentage of Remitters Based on the Hamilton Rating Scale for Depression (HAM-D) at Week 8(Week 8)
- Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) of Each Question's Score at Week 4(Baseline and Week 4)
- Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8(Baseline and Week 8)
- Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D)for Each Question's Score at Week 4(Baseline and Week 4)
- Percentage of Change From Baseline in Hamilton Rating Scale for Depression (HAM-D) for Each Question's Score at Week 8(Baseline and Week 8)
- Hamilton Rating Scale for Depression (HAM-D) Total Score at Week 4 and Week 8(Week 4 and Week 8)
- Percentage of Responders Based on the Clinical Global Impression - Global Improvement Score (CGI-I)at Week 4 and Week 8(Week 4 and Week 8)
- Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score at Weeks 1, 2, 3, 4, 8(Baseline, Weeks 1, 2, 3, 4, 8)
- Adverse Events (>=5% Incidence)(Baseline through Week 8)
- Serious Adverse Events(Baseline through Week 8)
研究者
研究点 (10)
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