NCT00650611已完成2 期
A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder
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 63 人开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Laboratory data at Screening and Weeks 3, 12, and 27.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
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
- None
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
- •Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
- •Willingness to discontinue all antipsychotic medications during the study period
排除标准
- •Patients who are clinically stable on treatments that are well tolerated
- •Substance-induced psychotic disorders
研究组 & 干预措施
Low-Dose Ziprasidone
Active Comparator
干预措施: Ziprasidone (Drug)
High-Dose Ziprasidone
Active Comparator
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Laboratory data at Screening and Weeks 3, 12, and 27.
时间窗: 27 weeks
Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
时间窗: 27 weeks
Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27.
时间窗: 27 weeks
次要结局
- Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3.(3 weeks)
- Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27.(27 weeks)
- Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.(27 weeks)
- Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.(27 weeks)
- Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.(27 weeks)
- Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27.(27 weeks)
- Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27.(27 weeks)
研究者
研究点 (1)
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