Ameliorating Attention Problems in Children With Sickle Cell Disease (SCD)

Completed · Phase 3

Conditions studied: Sickle Cell Disease

In brief

The purpose of this study is to assess whether methylphenidate is effective in enhancing the cognitive performance of children with the HbSS or HbSC genotype of SCD who have sustained neurological complications on laboratory-based measures of sustained attention, reaction time, and executive functions, and indirectly, verbal short-term and long-term memory.

Key facts

Study ID

NCT01411280

Run by

Temple University

People needed

34

Starts

2006-06-01

Expected to finish

2009-05-01

Last updated by the study team

2015-04-30

Who can join

Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed Consent can be obtained from parent or care-giver and Assent can be obtained from the child
• Children with sickle cell disease (HbSS or HbSC)
• Age range from 6 to 16 years inclusive
• English is the child's primary language
• T-score greater than or equal to 63 on either the Conners' Parent Rating Scale - Revised or the Conners' Teacher Rating

You may not qualify if…

• History of glaucoma for which methylphenidate is contraindicated
• Child or immediate family member has a history of a tic disorder or Tourette's syndrome
• Child is currently receiving antidepressant, anxiolytic, antipsychotic, or stimulant drug therapy
• Family history of substance abuse disorder due to potential for abuse of stimulants by caregivers or other family members
• Recent history of uncontrolled seizures (may be on anticonvulsants, provided seizures are under "reasonable" control and that the patient and family understand the risk of altered seizure control and potential interference with maintaining therapeutic levels of anticonvulsants)
• Hypothyroidism
• Symptoms of affective and mood disorders
• Previously diagnosed with ADHD prior to the onset of neurological complications (e.g., stroke or silent infarct) as documented in the medical record or caregiver report.
• Mental retardation (FSIQ < 70 on WASI)

Where it is running

• Temple University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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