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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07226219
Phase
PHASE1
Status
Recruiting
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Conditions

  • Attention Deficit/Hyperactivity Disorder (ADHD)
  • Cognitive Impairment
  • Executive Dysfunction
  • Sickle Cell Disease

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Extended-Release Methylphenidate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 25, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Assess feasibility of methylphenidate [ Time Frame: Feasibility is measured during the initial recruitment process for each participant. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Andrew Heitzer, PhD
[email protected]
888-226-4343
Andrew K Heitzer, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Sickle cell disease
By research site
St. Jude Children's Research Hospital· Memphis, TN

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