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

Inclusion criteria

• Diagnosed with SCD
• Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
• Between the ages of 8.0 and 17.9 years
• \*Included if performance measure, rating scale or diagnostic criteria met (within the past 2 years):
• \*Score at or below a Standard Score of 85 (16th percentile) on any 2 out of 4 performance measures:
• NIH Toolbox Flanker
• NIH Toolbox List Sorting
• NIH Toolbox Dimensional Change Card Sort Test (DCST)
• Wechsler Intelligence Scale for Children (WISC) -5/ Wechsler Adult Intelligence Scale (WAIS)-4 Digit Span Forward (DSF)
• \*Score at or above a T Score of 60 (84th percentile) on any 1 out of 2 parent rating scales:
• BRIEF-2 Global Executive
• BASC-3 Attention
• \*Have a documented diagnosis of attention deficit / hyperactivity disorder (any subtype)
• English as the primary language
• Research participant and one caregiver willing to participate and provide consent/assent according to institutional guidelines
• Negative pregnancy test in female participant of childbearing age

Exclusion criteria

• Primary language other than English
• Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test (ever)
• Uncontrolled seizures (seizure within the past 6 months)
• Cardiomyopathy or known congenital structural cardiac defects
• Stenotic valvular disease, left coronary artery stenosis, or history of myocarditis or pericarditis
• History of heart arrhythmia including ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, QT prolongation or concomitant use of medications associated with QT prolongation
• Two or more prior episodes of priapism
• Blood pressure \>95th percentile at the three most recent visits consecutively (i.e., \>95th percentile reading at all three of the most recent hospital visits to St. Jude).
• If blood pressure is \> 95th %ile compared to age-norms on the day of the baseline visit, a repeat blood-pressure reading will be performed both electronically and manually to confirm findings.
• Stimulant medication within the past two weeks
• Severe sensory loss
• Previous adverse reaction to methylphenidate
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Currently prescribed another investigational medication.
• Diagnosed with sickle cell-hereditary persistence of fetal hemoglobin (HbSHPFH), sickle cell homozygous C (CC), Hb S/N-Baltimore, or other rare genotypes that would preclude the participant from having the classic symptoms of sickle cell disease
• Currently prescribed any of the following:
• Phenobarbital (anticonvulsant)
• Phenytoin (anticonvulsant)
• Primidone (anticonvulsant)
• Warfarin (anticoagulant)
• Antipsychotic medications
• Selective Serotonin Reuptake Inhibitor (SSRI) medications
• Tricyclic antidepressant (TCA) medications
• Vasopressor medications