NCT00422123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 (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania
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
- 447
- 试验地点
- 51
- 主要终点
- Change from baseline to final visit in the YMRS total score
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.
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
- •Provision of written informed consent
- •Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
- •Inpatient hospital admission for the first 4 days of study treatment
排除标准
- •>8 mood episodes within the last 12 months
- •Use of prohibited medication
- •Substance or alcohol abuse or dependence
- •Current suicide risk or suicide attempt within last 6 months.
结局指标
主要结局
Change from baseline to final visit in the YMRS total score
次要结局
- Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
研究者
研究点 (51)
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