NCT01411280

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

Ameliorating Attention Problems in Children With SCD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Temple University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

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 production of abnormal hemoglobin (HbS), which causes red blood cells to assume a rigid, sickled shape upon release of oxygen, thereby reducing their viability in circulation. Consequently, chronic anemia and system-wide ischemia result in acute painful episodes, organ system failure, and neurological complications. Among the most debilitating effects of SCD are neurological complications. Despite the mounting evidence for structural and functional involvement of the frontal systems in pediatric SCD, there have been no clinical trials designed to manage the cognitive and behavioral sequelae associated with pediatric SCD.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	methylphenidate	Ritalin 10mg, Ritalin 20mg

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2011-08-08
• Last updated: 2015-04-30

Locations

2 sites across 1 country: United States