Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series

Recruiting

• Conditions: Smith Magenis syndrome; 17p11.2 deletion syndrome; 10083624; 10012562

• Registration Number: NL-OMON52697
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- A diagnosis of SMs confirmed with standard genetic testing (such as FISH
test, microarray, WES-analysis).
- Meet DSM-5 criteria for ADHD, and diagnosed with ADHD by a multidisciplinary
team consisting of an intellectual disability physician, a psychologist, and a
psychiatrist.
- Minimum age of six years old.
- Presence of a patient*s caregiver for proxy-reports.

Exclusion Criteria

- Presence of a contra-indication for treatment with methylphenidate.
- Planned general anaesthesia during the trial.
- Pregnancy.
- Breastfeeding females.
- Females of childbearing potential must be willing to use an effective method
of contraception from the time consent is signed until 6 weeks after treatment
discontinuation and inform the trial if pregnancy occurs.
- During treatment with non-selective, irreversible monoamine oxidase (MAO)
inhibitors, or within a minimum of 14 days of discontinuing those drugs.
- Current substance or alcohol abuse.
- Unable to swallow tablets / capsules.

Study & Design

• Study Type: Interventional
• Study Design: Not specified