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

Amsterdam UMC0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•A diagnosis of SMS confirmed with standard genetic testing.
•- 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.

•- 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 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 treatment with serotonergic drugs, acetazolamide, thiazide-diuretic and sodium bicarbonate, sympathicomimetics, tricyclic antidepressants, or anti-psychotics.
•- Current substance or alcohol abuse.
•- Unable to swallow capsules.

发起方

Amsterdam UMC