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

NCT ID
NCT07226219
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
St. Jude Children's Research Hospital
Conditions
Attention Deficit/Hyperactivity Disorder (ADHD), Cognitive Impairment, Executive Dysfunction, Sickle Cell Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Pilot Trial of Stimulant Treatment to Address Attention and Executive Deficits Among Children With Sickle Cell Disease

Enrollment: 72 participants (Estimated).

What is being studied

  • Intervention: 5,10-dihydro-5-methylphenazine
  • Drug: Extended-Release Methylphenidate

Who may be eligible

Ages
8 Years to 17 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Tennessee, United States: 1

Sample of listed locations

  • St. Jude Children's Research Hospital — Memphis, Tennessee, 38105, United States — Recruiting

Study details

Start date
November 25, 2025
Primary completion date
July 1, 2027
Completion date
August 1, 2028
First posted
November 10, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07226219
Registry last updated
September 9, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07226219 on ClinicalTrials.gov

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