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

NCT01411280 | Completed Phase 3

• 1 other identifier: R21HD049244-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Conners Parent and teacher Rating Scale

  1 week

Secondary Outcomes (1)

• Childrens Verbal Learning Test

  4 hours

Study Arms (2)

Laboratory trial

PLACEBO COMPARATOR

Compare methylphenidate to placebo in an acute laboratory trial

Drug: methylphenidate

Home/School trial

EXPERIMENTAL

Low dose and moderate dose methylphenidate are compared to placebo in a home and school trial

Drug: methylphenidate

Interventions

methylphenidate DRUG

Ritalin 10mg, Ritalin 20mg

Also known as: Ritalin

Home/School trial; Laboratory trial

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Temple University: lead

Study Sites (2)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ronald T Brown, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: August 8, 2011
• Study Start: June 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 30, 2015

Record last verified: 2011-08

Locations

US (2)