NCT00650429已完成4 期
Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
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 28 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from baseline to endpoint in Brief Psychiatric Rating Scale (BPRS) total score
研究概览
简要总结
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder.
- •Inpatients with acute exacerbation of psychotic symptoms.
- •Patients with a minimum score of 40 on the BPRS scale (1-7).
排除标准
- •Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
- •Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
- •Patients currently receiving clozapine.
- •Patients at immediate risk of committing harm to self or others.
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 to endpoint in Brief Psychiatric Rating Scale (BPRS) total score
时间窗: Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO)
次要结局
- Change from baseline to endpoint in Clinical Global Impressions-Severity (CGI-S) scale score(Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
- Change from baseline to endpoint in Clinical Global Impressions-Improvement (CGI-I) scale score(Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
- Simpson-Angus Scale (SAS)(Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO))
- Barnes Akathisia Scale (BAS)(Days 1 and 2 (IM), Day 4 (Switch), and Weeks 2 and 6 (PO))
- Electrocardiogram(Screening and Week 6)
- Laboratory tests(Screening and Week 6)
- Adverse events(Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
- Abnormal Involuntary Movement Scale (AIMS)(Day 1 (IM), Day 4 (Switch), and Week 6 (PO))
- Change from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) total score(Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
- Change from baseline to endpoint in Covi Anxiety Scale score(Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
- Change from baseline to endpoint in Positive PANSS subscale score(Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
- Change from baseline to endpoint in Negative PANSS subscale score(Screening, Days 1-3 (IM), Day 4 (Switch), Days 5-7 and Weeks 2, 4, and 6 (PO))
研究者
研究点 (1)
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