A Multicenter, Double-Blind, Randomized Trial Of Ziprasidone (80 - 160 Mg) Versus Olanzapine (10 - 20 Mg) In Patients With Recent-Onset Schizophrenia, Schizoaffective And Schizophreniform Disorder.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- The effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy in a 8 week period from the baseline visit to the end of week 8 visit.
研究概览
简要总结
This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the findings of an open study -where stable patients receiving olanzapine switched to ziprasidone- which showed maintenance of clinical effect with improvements in all domains of cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a well-controlled double-blind fashion will allow an evaluation of the effect on cognitive function in the short and long-term management of patients with recent-onset schizophrenia, schizoaffective and schizophreniform disorder.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of illness < 5 years (according to DSM-IV and onset first psychotic episode); CGI severity score > 4 (moderately ill)
- •maximum exposure to antipsychotic treatment of =< 16 weeks.
排除标准
- •Concurrent treatment with antipsychotic agents =< 12 hours prior to randomization
- •for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and randomization
- •Treatment with antidepressants or mood stabilizers =< 7 days of randomization
- •for MAOIs and moclobemide this period must =< 2 weeks
- •for fluoxetine =< 5 weeks
结局指标
主要结局
The effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy in a 8 week period from the baseline visit to the end of week 8 visit.
次要结局
- - to demonstrate effect on cognitive function of ziprasidone and olanzapine in the management of recent-onset psychosis, measured as the difference in efficacy over a 24-week and one year period from baseline visit to the end of week 24 and week 52 visit