NCT00388973已完成3 期
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 338
- 试验地点
- 43
- 主要终点
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
研究概览
简要总结
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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
- 66 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.
排除标准
- •The presence of dementia or mental disorder other than MDD within 6 months of enrolment,
- •Uncontrolled hypertension, substance or alcohol abuse
- •A current diagnosis of cancer or a current or past diagnosis of stroke
结局指标
主要结局
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
时间窗: Baseline to Week 9
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.
次要结局
- Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)(Baseline to Week 9)
- Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)(Baseline to Week 9)
- Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)(Baseline to Week 9)
- Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index(Baseline to Week 9)
- Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10(Baseline to Week 9)
- Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)(Baseline to Week 9)
- Tolerability as Measured by Adverse Event Withdrawals During Treatment(Baseline to Week 9)
研究者
研究点 (43)
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