Phenylketonuria, ADHD
Conditions
Interventions
Trade Name: Medikinet
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Amsterdam UMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the effectiveness of methylphenidate in reduction of ADHD symptomatology, operationalized by personalized goals that are important to the patient and its environment, in individuals with late-diagnosed PKU. ;Secondary Objective: To determine the effect of methylphenidate on emotion dysregulation. ;Primary end point(s): The primary outcome measure is GAS to identify and measure individualized goals with regard to the most obstructing symptoms experienced by caretakers.;Timepoint(s) of evaluation of this end point: End of (interventional) periods | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures are the hyperactivity / inattention subscale of the Strengths and Difficulties Questionnaire (SDQ), the Dutch version of the Emotion Dysregulation Inventory (EDI) reactivity index, and the PQ as a symptom list to compare assessments of personalized goals with those measured by GAS. ;Timepoint(s) of evaluation of this end point: End of (interventional) periods. | — |
Countries
Netherlands
Contacts
Public ContactEmma Children's Hospital
Amsterdam UMC
Outcome results
None listed