Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression
- Conditions
- NeurotoxicityUnspecified Childhood Solid Tumor, Protocol SpecificDepression
- Interventions
- Drug: Adderall-XR®
- Registration Number
- NCT00069927
- Lead Sponsor
- University of South Florida
- Brief Summary
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.
- Detailed Description
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.
Depression and neurocognitive function are assessed at baseline, 3 weeks, and end of study.
PROJECTED ACCRUAL: A total of 177 patients (approximately 88 per treatment arm) will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1- Adderall- XR® Concerta® Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response Arm 1- Adderall- XR® Adderall-XR® Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response Arm II Concerta® Adderall-XR® Concerta ® 18 mg/day for 3-12 weeks depending on subject's response Arm II Concerta® Concerta® Concerta ® 18 mg/day for 3-12 weeks depending on subject's response
- Primary Outcome Measures
Name Time Method 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 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (9)
St. Joseph's Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
CHRISTUS Santa Rosa Children's Hospital
🇺🇸San Antonio, Texas, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Sacred Heart Children's Hospital
🇺🇸Pensacola, Florida, United States
CCOP - Florida Pediatric
🇺🇸Tampa, Florida, United States
MBCCOP - South Texas Pediatrics
🇺🇸San Antonio, Texas, United States
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States