Ameliorating Attention Problems in Children With SCD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Conners Parent and teacher Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Laboratory trial
Compare methylphenidate to placebo in an acute laboratory trial
干预措施: methylphenidate (Drug)
Home/School trial
Low dose and moderate dose methylphenidate are compared to placebo in a home and school trial
干预措施: methylphenidate (Drug)
结局指标
主要结局
Conners Parent and teacher Rating Scale
时间窗: 1 week
次要结局
- Childrens Verbal Learning Test(4 hours)