Tests methylphenidate for attention and thinking problems in children with sickle cell disease
Tests a daily attention medicine in children with sickle cell disease and thinking problems.
Plain-language title generated from the registry record
Registry title: Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
Key facts
- Where
- Memphis, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 17 years old?
Source: NCT07226219, who can take part
Where in United States
- St. Jude Children's Research HospitalMemphis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Jude Children's Research Hospital
- Trial code
- NCT07226219
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
Pilot Trial of Stimulant Treatment to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
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 caregivers.
Inclusion: 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: Two or more prior episodes of priapism; Stimulant medication within the past two weeks; Previous adverse reaction to methylphenidate; 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; 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; 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; 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; Primary language other than English; Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test (ever); Severe sensory loss; Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.