NCT00119652已完成3 期
Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)
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
- 676
- 试验地点
- 56
- 主要终点
- Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.
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
- •Male and female out-patients aged 18 to 65 years inclusive
- •Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed
排除标准
- •Current period of depression lasting less than 4 weeks or more than 12 months
- •Use of prohibited medication
- •Substance or alcohol dependence or abuse
- •Current suicide risk or suicide attempt within 6 months
- •Breast feeding or pregnancy
- •Clinically relevant disease or clinical finding
结局指标
主要结局
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
次要结局
- Secondary variables supportive to the primary objective:
- MADRS total score response
- MADRS total score remission
研究者
研究点 (56)
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