Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression
NCT ID: NCT00069927
Last Updated: 2014-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2003-08-31
2006-09-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1- Adderall- XR®
Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response
Adderall-XR®
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Concerta®
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Arm II Concerta®
Concerta ® 18 mg/day for 3-12 weeks depending on subject's response
Adderall-XR®
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Concerta®
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Interventions
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Adderall-XR®
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Concerta®
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of any malignancy that required CNS treatment such as surgery and/or irradiation and/or intrathecal chemotherapy. (Patients treated with systemic chemotherapy alone are not eligible to participate)
* Off treatment and cancer free for a minimum of 6 months.
* Have a proficiency in English.
Exclusion Criteria
* At least one standard deviation below the level of performance predicted by their IQ on at least 2 of the 3 WISC-III subtests.
* Diagnosed with Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD) prior to their cancer diagnosis.
* Currently taking antidepressants, antipsychotics, or other stimulants.
* Are blind.
* Have glaucoma.
* Family history of motor and phonic tics or Tourette's syndrome.
* Have seizures not controlled by antiepileptic drugs. (Note: Patients who are not experiencing seizure activity, having been on a stable dose of an antiepileptic drug for at least 12 weeks may participate)
* Taking a monoamine oxidase (MAO) inhibitor.
* Have a history of cardiovascular disease, uncontrolled hypertension or hyperthyroidism.
6 Years
17 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of South Florida
OTHER
Responsible Party
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Principal Investigators
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Margaret Booth-Jones, PhD
Role: STUDY_CHAIR
University of South Florida
Locations
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University of Florida Shands Cancer Center
Gainesville, Florida, United States
Sacred Heart Children's Hospital
Pensacola, Florida, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States
CCOP - Florida Pediatric
Tampa, Florida, 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
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States
Countries
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Other Identifiers
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HLMCC-0201
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF-0201
Identifier Type: OTHER
Identifier Source: secondary_id
SCUSF 0201
Identifier Type: -
Identifier Source: org_study_id
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