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

Temple University

Status and phase

Completed

Phase 3

Conditions

Sickle Cell Disease

Treatments

Drug: methylphenidate

Study type

Interventional

Funder types

Other

Identifiers

NCT01411280

R21HD049244-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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)