Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069927
Status:
TERMINATED
Last Update Posted:
2014-02-03
First Post:
2003-10-03
Brief Title:
Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory Attention and Depression
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients A Randomized Phase II Study
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only 12 subjects enrolled DSMB recommended closing due to lack of feasibility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCUSF-0201 | OTHER | SunCoast CCOP Research Base | httpsreporternihgovquickSearchU10CA081920 |
| HLMCC-0201 | OTHER | None | None |
| U10CA081920 | NIH | None | None |