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

Sickle Cell Disease Clinical Trial

Official title:

Ameliorating Attention Problems in Children With SCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411280
• Other study ID #: R21HD049244-01
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2006
• Last updated: April 29, 2015
• Start date: June 2006
• Est. completion date: May 2009

Study information

• Verified date: August 2011
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• methylphenidate
Ritalin 10mg, Ritalin 20mg

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Parent and teacher Rating Scale		1 week	No
Secondary	Childrens Verbal Learning Test		4 hours	No