ISRCTN68384912已完成不适用
A double-blind, placebo-controlled trial of methylphenidate in children with hyperkinetic disorder and moderate-severe learning disabilities
King's College London (UK)0 个研究点目标入组 180 人开始时间: 2006年5月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
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
- 性别
- All
入选标准
- •1. Diagnosis of International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10) hyperkinetic disorder
- •2. Full-scale IQ 30-69 or age equivalent estimate
- •3. Living in catchment area of one of the participating centres
- •4. Child in stable care situation
- •5. Child regularly attending school (more than 75% of last school term)
排除标准
- •1. Child currently in another trial of psychoactive medication
- •2. Household member with recent diagnosis of substance abuse
- •3. Severe limitation of child's mobility
- •4. Presence of a degenerative disorder
- •5. Medical conditions precluding methylphenidate as treatment of first choice, including:
- •a. Poorly controlled or uncontrolled epilepsy
- •b. Presence of tics or Tourette disorder
- •c. History of psychotic, bipolar or severe obsessive compulsive disorder
- •d. Child on neuroleptic medication (must be withdrawn for 2 months prior to trial assessment)
- •e. History of intolerance to stimulant medication
- •f. Child poses a significant risk of suicidal or homicidal behaviour
- •6. Another child in the family/household already enrolled in this study
- •7. Ongoing child protection concerns
研究者
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