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

Sponsor
University of South Florida (Other)
Overall Status
Terminated
CT.gov ID
NCT00069927
Collaborator
National Cancer Institute (NCI) (NIH)
12
Enrollment
9
Locations
2
Arms
37
Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study
Study Start Date :
Aug 1, 2003
Actual Primary Completion Date :
Jun 1, 2006
Actual Study Completion Date :
Sep 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1- Adderall- XR®

Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response

Drug: Adderall-XR®
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Other Names:
  • dextroamphetamine-amphetamine

    • Drug: Concerta®
    Concerta® 18 mg/day for 3-12 weeks depending on subject's response
    Other Names:
  • methylphenidate hydrochloride

    		•
    Experimental: Arm II Concerta®

    Concerta ® 18 mg/day for 3-12 weeks depending on subject's response

    Drug: Adderall-XR®
    Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
    Other Names:
  • dextroamphetamine-amphetamine

    • Drug: Concerta®
    Concerta® 18 mg/day for 3-12 weeks depending on subject's response
    Other Names:
  • methylphenidate hydrochloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [12 weeks]

    Secondary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Shands Cancer Center Gainesville Florida United States 32610-0296
    2 Sacred Heart Children's Hospital Pensacola Florida United States 32504
    3 St. Joseph's Children's Hospital of Tampa Tampa Florida United States 33677-4227
    4 CCOP - Florida Pediatric Tampa Florida United States 33682-7757
    5 MBCCOP-Medical College of Georgia Cancer Center Augusta Georgia United States 30912-4000
    6 William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan United States 48073
    7 Wilford Hall Medical Center Lackland Air Force Base Texas United States 78236-5300
    8 CHRISTUS Santa Rosa Children's Hospital San Antonio Texas United States 78207
    9 MBCCOP - South Texas Pediatrics San Antonio Texas United States 78229-3900

    Sponsors and Collaborators

    • University of South Florida
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Margaret Booth-Jones, PhD, University of South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT00069927
    Other Study ID Numbers:
    • SCUSF 0201
    • HLMCC-0201
    • U10CA081920
    • SCUSF-0201
    First Posted:
    Oct 7, 2003
    Last Update Posted:
    Feb 3, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by University of South Florida
    unspecified childhood solid tumor, protocol specific
    depression
    neurotoxicity
    Additional relevant MeSH terms:
    Neurotoxicity Syndromes
    Depression
    Depressive Disorder
    Methylphenidate
    Amphetamine
    Adderall
    Dextroamphetamine

    Study Results

    No Results Posted as of Feb 3, 2014