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

Primary Purpose

Sickle Cell Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

methylphenidate

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Temple University
Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Laboratory trial

Home/School trial

Arm Description

Compare methylphenidate to placebo in an acute laboratory trial

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

Outcomes

Primary Outcome Measures

Conners Parent and teacher Rating Scale

Secondary Outcome Measures

Childrens Verbal Learning Test

Full Information

NCT ID

NCT01411280

First Posted

July 20, 2006

Last Updated

April 29, 2015

Sponsor

Temple University

1. Study Identification

Unique Protocol Identification Number

NCT01411280

Brief Title

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

Official Title

Ameliorating Attention Problems in Children With SCD

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Temple University

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laboratory trial

Arm Type

Placebo Comparator

Arm Description

Compare methylphenidate to placebo in an acute laboratory trial

Arm Title

Home/School trial

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

methylphenidate

Other Intervention Name(s)

Ritalin

Intervention Description

Ritalin 10mg, Ritalin 20mg

Primary Outcome Measure Information:

Title

Conners Parent and teacher Rating Scale

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Childrens Verbal Learning Test

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald T Brown, PhD

Organizational Affiliation

Temple University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Temple University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

12. IPD Sharing Statement

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

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