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

Phase 3

Completed

• Conditions: Sickle Cell Disease
• Interventions: Drug: methylphenidate

• Registration Number: NCT01411280
• Lead Sponsor: Temple University

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 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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-20
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Home/School trial	methylphenidate	Low dose and moderate dose methylphenidate are compared to placebo in a home and school trial
Laboratory trial	methylphenidate	Compare methylphenidate to placebo in an acute laboratory trial

Primary Outcome Measures

Name	Time	Method
Conners Parent and teacher Rating Scale	1 week

Secondary Outcome Measures

Name	Time	Method
Childrens Verbal Learning Test	4 hours

Trial Locations

Locations (2)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States