Actively Recruiting
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
Led by St. Jude Children's Research Hospital · Updated on 2026-04-23
72
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with sickle cell disease of any genotype
- Enrolled in the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
- Between 8.0 and 17.9 years old
- Have performance scores at or below the 16th percentile on any 2 of 4 tests (NIH Toolbox Flanker, List Sorting, Dimensional Change Card Sort Test, or WISC/WAIS Digit Span Forward)
- Have scores at or above the 84th percentile on 1 of 2 parent rating scales (BRIEF-2 Global Executive or BASC-3 Attention)
- Have a documented diagnosis of any subtype of attention deficit/hyperactivity disorder
- English as the primary language
- Participant and one parent willing to consent/assent
- Negative pregnancy test
You will not qualify if you...
- Primary language other than English
- IQ below the 2nd percentile on the WASI-2 test
- Uncontrolled seizures within the past 6 months
- Cardiomyopathy or congenital heart defects
- Stenotic valvular disease, left coronary artery stenosis, or history of myocarditis or pericarditis
- History of heart arrhythmias such as ventricular tachycardia or fibrillation
- Two or more prior episodes of priapism
- Blood pressure above the 95th percentile at the last three hospital visits
- Stimulant medication use within the past two weeks
- Severe sensory loss
- Previous adverse reaction to methylphenidate
- Inability or unwillingness to give informed consent
- Currently taking another investigational medication
- Taking phenobarbital, phenytoin, primidone, warfarin, antipsychotics, SSRIs, TCAs, or vasopressors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
A
Andrew Heitzer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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