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

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ClinicalTrials.gov Identifier: NCT01411280
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: methylphenidate Phase 3

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  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ameliorating Attention Problems in Children With SCD
Study Start Date : June 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Conners Parent and teacher Rating Scale [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Childrens Verbal Learning Test [ Time Frame: 4 hours ]


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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01411280     History of Changes
Other Study ID Numbers: R21HD049244-01 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: August 2011

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