NCT01157559已完成4 期
Efficacy and Safety With Ziprasidone in the Treatment of First-episode Schizophrenia Spectrum Disorder: Multi-center Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 3
- 主要终点
- Symptoms assessment by objective rating scales
研究概览
简要总结
The aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.
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
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet DSM-IV criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder
排除标准
- •Patients with previously prescribed antipsychotic medication in 2 weeks or more
- •patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
结局指标
主要结局
Symptoms assessment by objective rating scales
时间窗: week 8
PANSS total score, SANS, clinical global impression scale, GAF, DAS-S
Symptoms assessment by objective rating scales
时间窗: week 1
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
时间窗: week 2
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
时间窗: week 4
PANSS total score, SANS, clinical global impression scale, GAF
Symptoms assessment by objective rating scales
时间窗: week 6
PANSS total score, SANS, clinical global impression scale, GAF
次要结局
- Assessment of adverse events by objective rating scales and self report scales(two-month.)
- Assessment of adverse events by objective rating scales and self report scales(one-month)
研究者
研究点 (3)
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不适用
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