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
  Purpose

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 Intervention Phase
Depression
Neurotoxicity
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: Adderall-XR®
Drug: Concerta®
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: August 2003
Study Completion Date: September 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: dextroamphetamine-amphetamine
Drug: Concerta®
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Other Name: 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 Name: dextroamphetamine-amphetamine
Drug: Concerta®
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Other Name: methylphenidate hydrochloride

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069927

Locations
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0296
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
United States, Georgia
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
United States, Michigan
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Texas
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States, 78236-5300
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, United States, 78207
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Margaret Booth-Jones, PhD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00069927     History of Changes
Other Study ID Numbers: SCUSF 0201, HLMCC-0201, U10CA081920, SCUSF-0201
Study First Received: October 3, 2003
Last Updated: January 31, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government

Keywords provided by University of South Florida:
unspecified childhood solid tumor, protocol specific
depression
neurotoxicity

Additional relevant MeSH terms:
Depression
Depressive Disorder
Neurotoxicity Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Dextroamphetamine
Methylphenidate
Adderall
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014