About this trial
The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects.
The study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not.
Primary Objective:
• Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits.
Secondary Objective:
• Evaluate neurobehavioral and safety outcomes following MPH treatment.
Exploratory Objective:
• Evaluate decision-making and determinants influencing methylphenidate utilization among parents.
Eligibility criteria
Qualifiers
Diagnosed with SCD of any genotype
Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
Between the ages of 8.0 and 17.9 years
NIH Toolbox Flanker
Disqualifiers
Primary language other than English
Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test
Uncontrolled seizures (seizure within the past 6 months)
Cardiomyopathy or known congenital structural cardiac defects
Trial design
Treatments tested in this trial
- Extended-Release Methylphenidate