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Clinical Trials/NL-OMON52697
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

Academisch Medisch Centrum0 sites6 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

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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