NCT00649064已完成4 期
A Multi-Center Study To Examine The Clinical Effects Of Cross Titration Of Antipsychotics With Ziprasidone In Subjects With 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 46 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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
研究概览
简要总结
The purpose of this study is to see if differences exist in outcome in patients with schizophrenia or schizoaffective disorder who were switched from other antipsychotics to ziprasidone.
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 65 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
- •Outpatients for at least 3 months on treatment with sulpiride, olanzapine, quetiapine, or risperidone and at least a partial beneficial response to typical antipsychotic treatment including for the current episode
- •Partial improvement in symptoms that justified a switch to ziprasidone
排除标准
- •Diagnosis of major depression or occurrence of moderate depressive symptoms
- •Resistance to conventional antipsychotic drugs
- •Treatment with other drugs such as antiseizure medications, antipsychotics, antidepressants, or mood stabilizing agents that might interfere with the assessement of the efficacy of ziprasidone
研究组 & 干预措施
Ziprasidone
Experimental
干预措施: Ziprasidone (Drug)
结局指标
主要结局
Change from baseline in Brief Psychiatric Rating Scale (BPRS) total score
时间窗: Week 6
次要结局
- Change from baseline in weight(Baseline and Week 6)
- Change from baseline in prolactin and lipid levels(Baseline and Week 6)
- Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores(Baseline and Weeks 1, 2, and 6)
- Adverse events(Weeks 1, 2, and 6)
- Change from baseline in electrocardiogram(Baseline and Week 6)
- Clinical Global Impressions-Improvement (CGI-I) scale scores(Baseline (using historical data) and Weeks 1, 2, and 6)
- Change from baseline in movement disorder rating scales, including Barnes Akathisia Scale (BAS) and Abnormal Involuntary Movement Scale (AIMS)(Baseline and Week 6)
- Change from baseline in vital signs(Baseline and Weeks 1, 2, and 6)
- Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS) scores(Baseline and Week 6)
- Change from baseline in Positive and Negative Symptom Scale (PANSS), including PANSS total scores and PANSS positive, PANSS negative, and PANSS general subscale scores(Baseline and Weeks 1, 2, and 6)
研究者
研究点 (1)
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