NCT00454883已完成不适用
Treatment Of Manic Or Mixed Episodes Of Up To Moderate Severity In Patients With Bipolar Disorder And Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点目标入组 379 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 379
- 主要终点
- Changes in manic symptoms over course of treatment
研究概览
简要总结
Assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.
详细描述
Method: Consecutive patient sampling. Patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Manic and mixed episodes of up to moderate severity in patients with Type I and II bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes
排除标准
- •Hypersensitivity to ziprasidone
- •prolonged QTc interval
- •coadministration with substances that are prolonging the QTc interval
- •recent acute MI, cardiac failure, patients with arrhythmias treated with class IA or III medicaments
研究组 & 干预措施
1 cohort of patients treated with ziprasidone
干预措施: ziprasidone (Drug)
结局指标
主要结局
Changes in manic symptoms over course of treatment
时间窗: 3 months
Recording of extrapyramidal symptoms
时间窗: 3 months
Clinical global impression
时间窗: 3 months
次要结局
- Adverse Events(3 months)
- Severity of disease(3 months)
研究者
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