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

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborator: National Cancer Institute (NCI)
• Treatments: Adderall; Amphetamine; Dextroamphetamine; Methylphenidate

Criteria

INCLUSION CRITERIA:

• 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.

EXCLUSION CRITERIA:

• 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.