Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression

Stopped early · Phase 2

Conditions studied: Depression, Neurotoxicity, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT00069927

Run by

University of South Florida

People needed

12

Starts

2003-08-01

Expected to finish

2006-09-01

Last updated by the study team

2014-02-03

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between the ages of 6-17 at the time of study participation.
• 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.

You may not qualify if…

• Patients with an estimated intelligence quotient (IQ) of less than 65 (based on the Wide Range Achievement Test (WRAT-3) Reading subtest) are not eligible to continue on study.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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