Methylphenidate for ADHD in Smith-Magenis syndrome

• Conditions: Smith-Magenis syndrome; ADHD

• Registration Number: NL-OMON20117
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure includes the Strengths and Difficulties Questionnaire (SDQ) (subscale hyperactivity/inattention).

Secondary Outcome Measures

Name	Time	Method
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.