EUCTR2020-003660-11-NL进行中（未招募）1 期
Do effects of methylphenidate decline after long-term use? A double-blind, placebo-controlled cross-over study of effects of methylphenidate on cognitive functioning and real world behavior in treatment naïve children compared to effects after 9 months of treatment in clinical practice - MEDUSA
Accare0 个研究点目标入组 60 人开始时间: 2020年12月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Children between the ages 6 and 12, any ethnicity or cultural background
- •Who have been diagnosed with ADHD as confirmed with the Parent Interview for Child Symptoms (PICS) (obtained during routine clinical assessment)
- •Who are going to start methylphenidate as per clinical decision
- •No use of methylphenidate for the past six months
- •Have a bodyweight of at least 20 kilograms
- •Deemed reliable and compliant with the protocol
- •Parents (or the legal guardian) and children (twelve years) have provided informed consent to participate in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Intellectual disability (based on available IQ below 70 or the clinical opinion of the investigator, taking into account relevant psychosocial information, e.g. educational level/academic achievements; or as confirmed by the IDS-2 IQ screener obtained in each participant, see section 7.1.2)
研究者
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