NCT01157585已完成4 期
Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 12
- 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 Paliperidone ER 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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.
排除标准
- •Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
- •Needing another nonantipsychotic psychotropic medication at enrollment
- •Having a serious or unstable medical illness.
- •Pregnant or lactating women or women without adequate contraception will be also excluded.
研究组 & 干预措施
drug
Other
干预措施: paliperidone ER (Drug)
结局指标
主要结局
Symptoms assessment by objective rating scales
时间窗: week 8
PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)
次要结局
- Assessment of adverse events by objective rating scales and self report scales profile(week 1)
- Assessment of adverse events by objective rating scales and self report scales(week 8)
研究者
Young Chul Chung
Professor of Psychiatry
Chonbuk National University Hospital
研究点 (12)
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