NCT00257166已完成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.1 个研究点 分布在 1 个国家目标入组 238 人开始时间: 2006年1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
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
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 I 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
- Double (Participant, 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
- 否
入选标准
- •DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years
排除标准
- •Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation
研究组 & 干预措施
Ziprasidone oral capsules
Experimental
干预措施: Ziprasidone oral capsules (Drug)
Placebo
Placebo Comparator
干预措施: placebo oral capsules (Drug)
结局指标
主要结局
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
时间窗: Baseline, Week 4
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
次要结局
- Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3(Baseline, Week 1, 2, 3)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4(Baseline, Week 1, 2, 3, 4)
- Clinical Global Impression - Improvement (CGI-I) Score(Week 1, 2, 3, 4)
研究者
研究点 (1)
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