EUCTR2021-001174-29-NL进行中（未招募）1 期
Effectiveness of methylphenidate in adults with phenylketonuria and attention-deficit/hyperactivity disorder: An N-of-1 series - MPH4PK
Amsterdam UMC0 个研究点目标入组 5 人开始时间: 2021年3月31日最近更新:
适应症
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
- 5
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
- •- Minimum age of 18 years.
- •- 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.
- •- Presence of a patient’s caregiver for proxy-reports.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Unable to take and/or send in dried blood spots.
- •- 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 substance or alcohol abuse.
- •- Unable to swallow tablets / capsules.
研究者
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