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

Not yet recruiting

• Conditions: PKU; PAH deficiency; 10027424; 10021605; 10009841

• Registration Number: NL-OMON50968
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is Goal Attainment Scaling. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are 1) the Strengths and Difficulties Questionnaire,<br /><br>2) Emotion Dysregulation Inventory (EDI), 3) the Personal Questionnaire (PQ) to<br /><br>identify the three most obstructive symptoms experienced by participants, 4)<br /><br>serum phenylalanine levels, and 5) adverse effects of methylphenidate. </p><br>