Study Stopped
Only 12 subjects enrolled. DSMB recommended closing due to lack of feasibility
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
4 other identifiers
interventional
12
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 depression
Started Aug 2003
Typical duration for phase_2 depression
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 3, 2003
CompletedFirst Posted
Study publicly available on registry
October 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 3, 2014
January 1, 2014
2.8 years
October 3, 2003
January 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (2)
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
Depression as measured by Children's Depression Inventory Short Version (CDI-S) at baseline, weeks 3 and 12
12 weeks
Study Arms (2)
Arm 1- Adderall- XR®
EXPERIMENTALAdderall-XR® 1 10 mg/day for 3-12 weeks depending on subject's response
Arm II Concerta®
EXPERIMENTALConcerta ® 18 mg/day for 3-12 weeks depending on subject's response
Interventions
Adderall-XR® 10 mg/day for 3-12 weeks depending on subject's response
Concerta® 18 mg/day for 3-12 weeks depending on subject's response
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- National Cancer Institute (NCI)collaborator
Study Sites (9)
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0296, United States
Sacred Heart Children's Hospital
Pensacola, Florida, 32504, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, 33677-4227, United States
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Margaret Booth-Jones, PhD
University of South Florida
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2003
First Posted
October 7, 2003
Study Start
August 1, 2003
Primary Completion
June 1, 2006
Study Completion
September 1, 2006
Last Updated
February 3, 2014
Record last verified: 2014-01