NCT07226219
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
Recruiting
PHASE1Ages 8–17InterventionalTreatmentSt. Jude Children's Research HospitalInvestigator-initiated
~72 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Extended-Release Methylphenidate
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess feasibility of methylphenidate
Measured over Feasibility is measured during the initial recruitment process for each participant.
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Andrew W. Heitzer, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
\*Score at or below the 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 the 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 parent willing to participate and provide consent/assent according to institutional guidelines
Negative pregnancy test
Exclusion
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
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.
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
What this trial measures
- Assess feasibility of methylphenidateFeasibility is measured during the initial recruitment process for each participant.
Feasibility is measured by the participation rate (i.e., ratio of those who agree to participate to those approached).
- Assess acceptability of methylphenidateAcceptability ratings are captured at baseline and after 4 weeks of treatment with methylphenidate.
Acceptability is captured by parent- and self-report ratings on the Acceptability of Intervention Measure (AIM).
- Assess adherence to methylphenidateAdherence is measured on a weekly basis through 4 weeks of treatment
Adherence is measured through weekly pill counts. The primary adherence outcome is the ratio of the number of pills taken to those dispersed.