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

Ameliorating Attention Problems in Children With SCD

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Drug: methylphenidate

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Laboratory trial; Compare methylphenidate to placebo in an acute laboratory trial	Drug: methylphenidate; Ritalin 10mg, Ritalin 20mg; Other Names: Ritalin
Experimental: Home/School trial; Low dose and moderate dose methylphenidate are compared to placebo in a home and school trial	Drug: methylphenidate; Ritalin 10mg, Ritalin 20mg; Other Names: Ritalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Conners Parent and teacher Rating Scale	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Childrens Verbal Learning Test	4 hours

Collaborators and Investigators

• Sponsor: Temple University
• Investigators: Principal Investigator: Ronald T Brown, PhD, Temple University

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: July 20, 2006
• First Submitted That Met QC Criteria: August 5, 2011
• First Posted (Estimate): August 8, 2011

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Methylphenidate
• Other Study ID Numbers: R21HD049244-01 (U.S. NIH Grant/Contract)