NCT00150605已完成3 期
A Phase IIIb, Open Label Observational Study of SPD417 Used in Combination With Other Psychotropic Medications for the Treatment of Bipolar I Disorder
Validus Pharmaceuticals0 个研究点目标入组 50 人开始时间: 2005年2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
- 50
- 主要终点
- Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
研究概览
简要总结
The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Screening YMRS score =>16
- •Women of childbearing potential agree to take adequate precautions against contraception
- •Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic
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
- •Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
结局指标
主要结局
Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
次要结局
- YMRS Scale
- Clinical Global Impressions Scale - Bipolar Version
- HAM-D and MADRS Scales for Depression
研究者
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