A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 171
- 试验地点
- 50
- 主要终点
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4
研究概览
简要总结
The purpose of this study is to determine if 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
- 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
- 否
入选标准
- •DSM V 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
1
干预措施: placebo oral capsules (Drug)
ziprasidone
干预措施: ziprasidone oral capsules (Drug)
结局指标
主要结局
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4
时间窗: Baseline, Week 4
YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) 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 was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.
次要结局
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4(Baseline, Week 1, 2, 3, 4)
- Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3(Baseline, Week 1, 2, 3)
- Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4(Baseline, Week 1, 2, 3, 4)