EUCTR2014-003718-10-NL进行中（未招募）1 期
A placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability - Discontinuation of risperidone in people with intellectual disability
MCG0 个研究点目标入组 120 人开始时间: 2015年9月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.IQ<70 as assessed by an authorized behavioral therapist
- •2.Age > 6 years
- •3.No history of chronic psychosis
- •4.Risperidone use>1 year
- •5.Challenging behavior was the reason of prescription of risperidone
- •6.Informed consent obtained from legal representative
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.A history of schizofrenia, a bipolar disorder, or affective psychosis according to DSM IV or ICD-10 criteria
- •2.A history of unsuccessful withdrawal of antipsychotics in the past 6 months
- •3.The use of other antipsychotics in addition to risperidone use
- •4.Risperidone is administered as long-acting injections
- •5.Clients that do not receive 24 hour/a day care (by either a service provider or parents/family)
研究者
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