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RECRUITING
NCT07226219
PHASE1

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

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-11-25

Completion Date

2028-08

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

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.

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States