Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 9
- 主要终点
- Response rate as measured by Wechsler Intelligence Scale for Children-III (WISC III) subtest: Coding, Symbol Search and Digit Span at baseline, and 3 weeks after the start of study treatment
研究概览
简要总结
RATIONALE: Stimulant drugs such as dextroamphetamine-amphetamine and methylphenidate may help improve memory, attention, and thinking problems caused by central nervous system (CNS) treatment for cancer, and may help decrease depression.
PURPOSE: This randomized phase II trial is studying dextroamphetamine-amphetamine to see how well it works compared to methylphenidate in treating depression and problems with memory, attention, and thinking in children who have undergone CNS treatment for cancer. This trial will also study how often depression is seen and if these medications might help.
详细描述
OBJECTIVES:
- Compare the response rates in pediatric cancer patients with treatment-related neurocognitive sequelae treated with dextroamphetamine-amphetamine (Adderall-XR®) vs methylphenidate (Concerta®).
- Compare the durability of response at 12 weeks in patients who show a response at 3 weeks after treatment with these drugs.
- Determine whether patients who have no response to one of these study drugs can respond to the other study drug.
- Determine the prevalence of depression and possible response to neurostimulant therapy in this patient population.
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral dextroamphetamine-amphetamine once daily for 3 weeks. Patients who achieve response (based on neurocognitive testing) continue treatment for a total of 12 weeks. Patients with no response after 3 weeks cross over to arm II after a 48-hour washout period.
- Arm II: Patients receive oral methylphenidate once daily for 3 weeks. Responding patients continue treatment for a total of 12 weeks. Patients with no response after 3 weeks cross over to arm I after a 48-hour washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1- Adderall- XR®
Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response
干预措施: Adderall-XR® (Drug)
Arm 1- Adderall- XR®
Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response
干预措施: Concerta® (Drug)
Arm II Concerta®
Concerta ® 18 mg/day for 3-12 weeks depending on subject's response
干预措施: Adderall-XR® (Drug)
Arm II Concerta®
Concerta ® 18 mg/day for 3-12 weeks depending on subject's response
干预措施: Concerta® (Drug)
结局指标
主要结局
Response rate as measured by Wechsler Intelligence Scale for Children-III (WISC III) subtest: Coding, Symbol Search and Digit Span at baseline, and 3 weeks after the start of study treatment
时间窗: 12 weeks
次要结局
- Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment(12 weeks)
- Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12(12 weeks)