NCT01117220撤回3 期
Four Week, Double Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.
研究概览
简要总结
The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)
- •At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least
- •The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive
排除标准
- •Imminent risk of suicide or homicide, as judged by the site investigator
- •Any history of serious or unstable illness
- •Risk for prolonged QT
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Active Comparator
干预措施: Ziprasidone Oral Capsules (Drug)
结局指标
主要结局
Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.
时间窗: 4 weeks
次要结局
- Change from baseline in Clinical Global Impression of Severity (CGI S) score.(4 weeks)
- Clinical Global Impression of Improvement (CGI I) score(4 weeks)
研究者
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