NL-OMON20117
Not Yet Recruiting
N/A
Effectiveness of methylphenidate in children and adults with Smith-Magenis syndrome and attention-deficit/hyperactivity disorder: An N-of-1 series
Amsterdam UMC0 sites6 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Smith-Magenis syndrome
- Sponsor
- Amsterdam UMC
- Enrollment
- 6
- Status
- Not Yet 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.
- •\- 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 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 treatment with serotonergic drugs, acetazolamide, thiazide\-diuretic and sodium bicarbonate, sympathicomimetics, tricyclic antidepressants, or anti\-psychotics.
- •\- Current substance or alcohol abuse.
- •\- Unable to swallow capsules.
Outcomes
Primary Outcomes
Not specified
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