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

This study has been terminated.
(Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00069927
First received: October 3, 2003
Last updated: January 31, 2014
Last verified: January 2014

October 3, 2003
January 31, 2014
August 2003
June 2006   (final data collection date for primary outcome measure)
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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00069927 on ClinicalTrials.gov Archive Site
  • Durability of response as measured by WISC III subtest: Coding, Symbol Search and Digit Span at 12 weeks after the start of study treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Adderall XR Compared With Concerta in Treating Young Cancer Patients With Memory, Attention, and Depression
Adderall-XR Versus Concerta For Cancer Treatment-Related Neurocognitive Sequelae And Depression In Pediatric Patients: A Randomized Phase II Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Depression
  • Neurotoxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Drug: Adderall-XR®
    Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
    Other Name: dextroamphetamine-amphetamine
  • Drug: Concerta®
    Concerta® 18 mg/day for 3-12 weeks depending on subject's response
    Other Name: methylphenidate hydrochloride
  • Experimental: Arm 1- Adderall- XR®
    Adderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response
    Interventions:
    • Drug: Adderall-XR®
    • Drug: Concerta®
  • Experimental: Arm II Concerta®
    Concerta ® 18 mg/day for 3-12 weeks depending on subject's response
    Interventions:
    • Drug: Adderall-XR®
    • Drug: Concerta®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
September 2006
June 2006   (final data collection date for primary outcome measure)

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.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069927
SCUSF 0201, HLMCC-0201, U10CA081920, SCUSF-0201
Yes
University of South Florida
University of South Florida
National Cancer Institute (NCI)
Study Chair: Margaret Booth-Jones, PhD University of South Florida
University of South Florida
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP