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

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT01411280
First received: July 20, 2006
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
 Drug: methylphenidate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ameliorating Attention Problems in Children With SCD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Temple University:

Primary Outcome Measures:
  • Conners Parent and teacher Rating Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Laboratory trial
Compare methylphenidate to placebo in an acute laboratory trial
 Drug: methylphenidate
Ritalin 10mg, Ritalin 20mg
Other Name: 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 Name: Ritalin

Detailed Description:

Sickle cell disease (SCD) is a group of autosomal recessive disorders, affecting an estimated 1 in 400 African American newborns annually (Charache et al., 1989). 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 (Embury et al., 1994; Kaul et al., 1989; Serjeant, 1992). 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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Active patients in the Sickle Cell Program at either St. Christopher's Hospital for Children and the Medical University of South Carolina or an affiliated satellite clinic
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411280

Locations
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Ronald T Brown, PhD Temple University
  More Information

No publications provided

Responsible Party: Ronald Brown, Temple University
ClinicalTrials.gov Identifier: NCT01411280     History of Changes
Other Study ID Numbers: R21 HD49244-01
Study First Received: July 20, 2006
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Methylphenidate
Dopamine Uptake Inhibitors
 Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013