Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age8-17
SponsorSt. Jude Children's Research Hospital

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

Treatment groups

72 Participants
are divided into 1 treatment group