Smith-Magenis syndrome
Conditions
Sponsors
Amsterdam UMC
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure includes the Strengths and Difficulties Questionnaire (SDQ) (subscale hyperactivity/inattention). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are the shortened version of the Emotion Dysregulation Inventory (EDI) reactivity index, Goal Attainment Scaling (GAS), the personal questionnaire (PQ), and adverse effects. | — |
Contacts
Public ContactAgnies van Eeghen
Amsterdam UMC / 's Heeren Loo
Outcome results
None listed