Effectiveness of methylphenidate for treating ADHD in adultswith PK

Phase 1

• Conditions: Phenylketonuria, ADHD; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2021-001174-29-NL
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-31
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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.
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

- 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 clinical trial of medicinal product
• Study Design: Not specified