Status:
COMPLETED
Ameliorating Attention Problems in Children With Sickle Cell Disease (SCD)
Lead Sponsor:
Temple University
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief 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 com...
Detailed Description
Sickle cell disease (SCD) is a group of autosomal recessive disorders, affecting an estimated 1 in 400 African American newborns annually. The pathophysiology of this group of disorders involves the p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01411280
Start Date
June 1 2006
End Date
May 1 2009
Last Update
April 30 2015
Active Locations (2)
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1
Temple University
Philadelphia, Pennsylvania, United States, 19140
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425