NL-OMON52697
Recruiting
Not Applicable
Effectiveness of methylphenidate in children and adults with Smith Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series - Methylphenidate for ADHD in Smith Magenis syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 6
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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