NCT00159120已完成4 期
Maintenance Treatment vs. Stepwise Drug Discontinuation After One Year of Maintenance Treatment in First-Episode Schizophrenia
Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2001年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- relapse rate
研究概览
简要总结
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions prodrome based early intervention take place.
详细描述
After one year neuroleptic maintenance treatment in patients with first episode schizophrenia, neuroleptic treatment will be continued vs. stepwise discontinued (randomized design) over a period of 1 year. Under both conditions pharmacologic early intervention strategies in case of early sign of relapse will be applied.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after 1 year of maintenance treatment after their first-episode in schizophrenia (according ICD-10 F20)
- •Age between 18 and 55
- •Informed consent
- •One year neuroleptic maintenance treatment
- •Reaching stable course
排除标准
- •Residence outside of the catchment area
- •Legal reasons
- •Insufficient knowledge of the german language
- •Substance abuse or addiction
- •Pregnancy
- •Serious physical illness
- •Organic brain disease
- •Contraindication to neuroleptic treatment
结局指标
主要结局
relapse rate
时间窗: 1 year
次要结局
- psychopathology(1 year)
- social and cognitive functioning(1 year)
- side-effects(1 year)
- drop-out(1 year)
- quality of life(1 year)
研究者
研究点 (2)
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