NCT00139074终止4 期
Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
研究概览
简要总结
The primary purpose is to investigate whether the addition of sodium valproate will be superior to treatment with quetiapine (Seroquel) given as monotherapy for an additional 14 days in non-responding patients after a 14 day initial treatment period with quetiapine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from a manic or mixed episode.
排除标准
- •Patients who have not provided personal informed consent,
- •Known intolerance, hypersensitivity or lack of antimanic response to sodium valproate or quetiapine fumarate,
- •Involuntary admittance/detainment.
研究组 & 干预措施
1
Active Comparator
quetiapine fumarate monotherapy
干预措施: Quetiapine fumarate (Drug)
2
Experimental
Quetiapine + sodium valproate
干预措施: Quetiapine fumarate (Drug)
2
Experimental
Quetiapine + sodium valproate
干预措施: sodium valproate (Drug)
结局指标
主要结局
The number of responders in the two treatment groups (quetiapine + sodium valproate placebo/quetiapine + sodium valproate)
时间窗: after 2 weeks treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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