NCT00150553已完成3 期
A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
Validus Pharmaceuticals0 个研究点目标入组 102 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 主要终点
- Score on Young Mania Rating Scale (YMRS) at 12 weeks
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV criteria for bipolar I disorder
- •Screen YMRS score => 16
- •Women of childbearing potential agree to take adequate precautions against contraception
排除标准
- •Hospitalization required for treatment of psychiatric symptoms
- •Patients who meet DSM-IV for ultra-rapid cycling
- •History of serious suicide attempt requiring medical intervention
结局指标
主要结局
Score on Young Mania Rating Scale (YMRS) at 12 weeks
次要结局
- Time to remission
- Clinical Global Impressions Scale - Bipolar Version
- HAM-D and MADRS scales for depression
研究者
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