NCT03090490Unknown不适用
Clinical Outcome After Antipsychotic Treatment Discontinuation in Functionally Recovered First-episode Non-affective Psychosis Individuals: a 10-year Follow-up
Fundación Marques de Valdecilla2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Relapse rate
研究概览
简要总结
This open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the ten years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals included in the First Episode Psychosis Clinical Program (PAFIP) at the University Hospital Marqués de Valdecilla (Santander, Spain).
- •A minimum of 18 months on antipsychotic treatment.
- •Meeting clinical remission criteria for at least the 12 months prior to inclusion.
- •Meeting the functional recovery criteria for at least the 6 months prior to inclusion.
- •Stabilized at the lowest effective doses for at least the 3 months prior to inclusion.
排除标准
- •Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for drug dependence.
- •Meeting DSM-IV criteria for mental retardation.
- •Having a history of neurological disease or head injury.
结局指标
主要结局
Relapse rate
时间窗: At 10 years
The percentage of relapse/exacerbation in the two groups of patients, discontinuation and maintenance.
次要结局
- Change in general psychopathology measured by BPRS(At 10 years)
- Change in overall clinical status measured by CGI(At 10 years)
- Change in negative symptoms measured by SANS(At 10 years)
- Change in negative symptoms measured by SAPS(At 10 years)
- Time to relapse(At 10 years)
- Functionality status measured by DAS(At 10 years)
研究者
Benedicto Crespo-Facorro
Associate Professor of Psychiatry
Fundación Marques de Valdecilla
研究点 (2)
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