NCT00645229终止3 期
Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset
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 1 人开始时间: 2004年9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
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms
详细描述
The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
- •Diagnosis of schizophrenia or schizoaffective disorder
- •Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years
排除标准
- •Patients at immediate risk of committing harm to self or others
- •Treatment with clozapine within 3 months prior to baseline
- •History of neuroleptic treatment
- •Current antipsychotic treatment
研究组 & 干预措施
Arm A
Experimental
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24
时间窗: Week 24
Change from baseline in PANSS (Depression-C) score at Week 24
时间窗: Week 24
Change from baseline in CGI-S total score at Week 24
时间窗: Week 24
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24
时间窗: Week 24
次要结局
- Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6(Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6)
- Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6(Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6)
- Electrocardiogram(Screening and Month 4)
- Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24(Week 24)
- Change from baseline in Global Assessment of Functioning (GAF) score at Week 24(Week 24)
- Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6(Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6)
- Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6(Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6)
- Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6(Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6)
研究者
研究点 (1)
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