Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease
NCT ID: NCT07226219
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2025-12-31
2028-08-31
Brief Summary
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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.
Detailed Description
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This is a single-arm, open-label pilot trial conducted at St. Jude Children's Research Hospital. Thirty children with SCD and EF deficits will receive a 4-week course of extended-release MPH (10 mg or 20 mg daily, based on weight). Extended-release methylphenidate will be administered once daily for 4 weeks. The initial dose will be given in clinic, followed by home administration. Adherence will be monitored via weekly video pill counts.
The study will enroll 30 patients aged 8.0 to 17.9 years with SCD and EF impairment, along with 30 caregivers. An additional 12 caregivers who decline participation will be interviewed to assess decision-making and treatment barriers.
Neurobehavioral assessments and side effect evaluations will be conducted at baseline, immediately post-dose, and weekly during the home medication phase. Parents will complete rating scales and interviews to assess treatment acceptability and decision-making.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Methylphenidate Treatment Group
All participants in this single-arm pilot study will receive extended-release methylphenidate for 4 weeks. The intervention is designed to evaluate feasibility, acceptability, adherence, and safety of stimulant treatment in children and adolescents with sickle cell disease (SCD) and executive functioning deficits.
Extended-Release Methylphenidate
Participants will receive a weight-based dose of extended-release methylphenidate (0.6 mg/kg/day), rounded to either 10 mg or 20 mg, taken orally once daily for 4 weeks.
Interventions
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Extended-Release Methylphenidate
Participants will receive a weight-based dose of extended-release methylphenidate (0.6 mg/kg/day), rounded to either 10 mg or 20 mg, taken orally once daily for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 or rating scale criteria met:
* \*Score 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 above the 84th percentile on any 1 out of 2 parent rating scales:
* BRIEF-2 Global Executive
* BASC-3 Attention
* 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 Criteria
* 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
* Uncontrolled or untreated hypertension
* 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
8 Years
17 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Andrew Heitzer, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew Heitzer, PhD
Role: primary
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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STARS
Identifier Type: -
Identifier Source: org_study_id