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

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression; Neurotoxicity; Unspecified Childhood Solid Tumor, Protocol Specific

Intervention: Adderall-XR® (Drug); Concerta® (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Margaret Booth-Jones, PhD, Study Chair, Affiliation: University of South Florida


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.

Clinical Details

Official title: Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: 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

Secondary outcome:

Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment

Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12

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.


Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.



- 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.


- 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


Locations and Contacts

University of Florida Shands Cancer Center, Gainesville, Florida 32610-0296, United States

Sacred Heart Children's Hospital, Pensacola, Florida 32504, United States

CCOP - Florida Pediatric, Tampa, Florida 33682-7757, United States

St. Joseph's Children's Hospital of Tampa, Tampa, Florida 33677-4227, United States

MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia 30912-4000, United States

William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan 48073, United States

Wilford Hall Medical Center, Lackland Air Force Base, Texas 78236-5300, United States

CHRISTUS Santa Rosa Children's Hospital, San Antonio, Texas 78207, United States

MBCCOP - South Texas Pediatrics, San Antonio, Texas 78229-3900, United States

Additional Information

Starting date: August 2003
Last updated: January 31, 2014

Page last updated: August 23, 2015

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