A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 584
- 试验地点
- 1
- 主要终点
- Time to Intervention for a Mood Episode During Double Blind Period
研究概览
简要总结
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
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
- •Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)
排除标准
- •Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome
研究组 & 干预措施
Ziprasidone
Active treatment, double-blind, randomized arm
干预措施: Ziprasidone Oral Capsule (Drug)
Placebo
Placebo treatment, double-blind, randomized arm
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Intervention for a Mood Episode During Double Blind Period
时间窗: Period 2: 24 weeks or time of early termination
Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.
次要结局
- Modified Time to Intervention for a Mood Episode (TIME)(Period 2: Week 24 or time of early termination)
- Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period(Period 2: Weeks 1 - 24 or time of early termination)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period(Period 2: Weeks 4 - 24 or time of early termination)
- Time to Discontinuation for Any Reason During Double Blind Period 2(Period 2: 24 weeks or time of early termination)
- Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period(Period 2: Weeks 1 - 24 or time of early termination)
- Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period(Period 2: Weeks 1 - 24 or time of early termination)
- Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period(Period 2: Weeks 1 - 24 or time of early termination)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period(Period 2: Weeks 4 - 24 or time of early termination)
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period(Period 2: Weeks 4 - 24 or time of early termination)