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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laboratory trial | Placebo Comparator | Compare methylphenidate to placebo in an acute laboratory trial |
|
| Home/School trial | Experimental | Low dose and moderate dose methylphenidate are compared to placebo in a home and school trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate | Drug | Ritalin 10mg, Ritalin 20mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conners Parent and teacher Rating Scale | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Childrens Verbal Learning Test | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald T Brown, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University | Philadelphia | Pennsylvania | 19140 | United States | ||
| Medical University of South Carolina |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2023 | |
| Reset | May 2, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2023 | May 2, 2023 |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Charleston |
| South Carolina |
| 29425 |
| United States |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |