NCT00048204已完成2 期
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 372
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)
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
- •Patients meet the diagnosis of Major Depressive Disorder (MDD).
排除标准
- •Patients with a primary diagnosis other than MDD.
- •Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder.
- •Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit.
- •Patient is actively suicidal.
- •Patients who have a history of migraine headaches.
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: 8 Weeks
次要结局
- Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale(8 Weeks)
研究者
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