NL-OMON43644已完成4 期
A placebo-controlled discontinuation trial of off-label used risperidone in people with intellectual disability - Discontinuation of risperidone in people with intellectual disability
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. IQ lower then 70 as assessed by an authorized behavioral therapist
- •2. Age over 6 years
- •3. No history of chronic psychosis
- •4. Risperidone use over1 year
- •5. Challenging behavior was the reason of prescription of risperidone
- •6. Informed consent obtained from legal representative
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)
- •6. Clients that are pregnant or intention to become pregnant
研究者
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