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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)