NCT00326105已完成3 期
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment (PEARL STUDY)
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
- 450
- 试验地点
- 56
- 主要终点
- To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to provide written informed consent before beginning any study related procedures
- •Patient has a documented clinical diagnosis of major depressive disorder
- •Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
排除标准
- •Patients with a history of non-compliance as judged by the study investigator
- •Patients with a known lack of response to previous treatment with quetiapine
- •Patients who have participated in a clinical trial within 4 weeks of randomization
结局指标
主要结局
To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS
次要结局
- To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone
- To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone
研究者
研究点 (56)
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