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临床试验/NL-OMON52697
NL-OMON52697招募中不适用

Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series - Methylphenidate for ADHD in Smith Magenis syndrome

Academisch Medisch Centrum0 个研究点目标入组 6 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
6

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

  • - A diagnosis of SMs confirmed with standard genetic testing (such as FISH
  • test, microarray, WES-analysis).
  • - Meet DSM-5 criteria for ADHD, and diagnosed with ADHD by a multidisciplinary
  • team consisting of an intellectual disability physician, a psychologist, and a
  • psychiatrist.
  • - Minimum age of six years old.
  • - Presence of a patient*s caregiver for proxy-reports.

排除标准

  • - Presence of a contra-indication for treatment with methylphenidate.
  • - Planned general anaesthesia during the trial.
  • - Pregnancy.
  • - Breastfeeding females.
  • - Females of childbearing potential must be willing to use an effective method
  • of contraception from the time consent is signed until 6 weeks after treatment
  • discontinuation and inform the trial if pregnancy occurs.
  • - During treatment with non-selective, irreversible monoamine oxidase (MAO)
  • inhibitors, or within a minimum of 14 days of discontinuing those drugs.
  • - Current substance or alcohol abuse.
  • - Unable to swallow tablets / capsules.

研究者

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