Effectiveness of methylphenidate in adults with phenylketonuria and attention-deficit/hyperactivity disorder: An N-of-1 series

Amsterdam UMC / Amsterdam Public Health (Personalized Medicine)0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•Minimum age of 18 years.
•- On or off Phe-restricted diet.
•- A definite diagnosis of classical PKU according to well-established guidelines.
•- Meet DSM-5 criteria for ADHD and diagnosed with ADHD by an expert multidisciplinary team consisting of an ID physician, a psychologist, and a psychiatrist.
•- Suffering from ADHD symptoms for which a dietary intervention would not suffice to improve behavioural problems.
•- Presence of a patient’s caregiver for proxy-reports.

•- Unable to take and/or send in dried blood spots.
•- Unable to obtain informed consent from legal representative.
•- Presence of ADHD in first- and second-degree relatives.
•- Presence of a contra-indication for treatment with methylphenidate (e.g. cardiovascular disease).
•- Planned surgery and/or general anaesthesia during the trial.
•- Pregnancy.
•- Breastfeeding (females).
•- During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of one month of discontinuing those drugs.
•- Current treatment with acetazolamide, thiazide-diuretic and sodium bicarbonate, or sympathicomimetics.
•- Current substance or alcohol abuse.
•- Unable to swallow tablets / capsules.

发起方

Amsterdam UMC / Amsterdam Public Health (Personalized Medicine)