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STARS: Methylphenidate for Attention Problems in Sickle Cell Disease

About this study

People with sickle cell disease (SCD) can have complications that affect how their brain works. This may include problems paying attention, remembering things, or learning new information. These problems can affect how well school-age children and teens perform at school and function in daily life.

Methylphenidate is a medicine that is approved by the U.S. Food and Drug Administration (FDA). It is used to treat problems with brain function, such as attention deficit hyperactivity disorder (ADHD) and with sleep disorders like narcolepsy. 

This study will test if taking methylphenidate is feasible, acceptable, and safe for children and teens who have problems with attention and learning that come from sickle cell disease. We also want to know what caregivers think about using this medicine.

Patients will have physical exams and screening electrocardiograms (EKGs) to check heart function. They will also take tests to study their thinking and attention. They will then take 1 dose of methylphenidate. After 90 minutes, they will do the same tests again to check for immediate changes in cognitive skills. They will be watched for 4 hours. Then they will be given methylphenidate to take at home as prescribed for 28 days (4 weeks).

During the 4-week take-home phase, they will have a video call meeting with a study nurse once a week. In this meeting, patients will report:

  • Any side effects 
  • If they were able to take methylphenidate
  • How many pills they used

The nurse will ask questions about their mood, behavior, thinking, and well-being. 

At the beginning and end of this study, researchers will interview 12 caregivers of the patients to find out what they think about the drug.

Eligibility overview

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The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

Overview

Full title:

Pilot Trial of Stimulant Treatment to Address Attention and Executive Deficits Among Children with Sickle Cell Disease

Study goal:

To study if methylphenidate is feasible and acceptable for complications of sickle cell disease that affect attention or thinking skills in children and teens, and to determine what caregivers think about the use of this medicine.

Diagnosis:

Sickle Cell Disease

Age:

8–17 years old

Clinical trial categories:

Blood Disorders Sickle Cell Disease

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.

 

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