Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear.

Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.
Study Started
May 31
Primary Completion
Nov 30
Study Completion
Nov 30
Results Posted
Nov 22
Last Update
Mar 27

Drug Methylphenidate

1 capsule each day for 1 week, .3 mg/kg dose.

  • Other names: Methylphenidate hydrochloride, Metadae CD (TM)

Drug Placebo

1 capsule per day for 1 week.

  • Other names: Inactive substance

Methylphenidate Active Comparator

Administered 1 capsule each day for 1 week, .3 mg/kg dose.

Placebo Placebo Comparator

Administered 1 capsule each day for 1 week.


Inclusion Criteria:

Initial Screening and Registration

Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview.
Proficient in English
Have given informed consent (assent)

After Initial Screening

Have evidence of attention impairment based on parent report of attention deficit (> and = 75% on attention deficit hyperactivity disorder [ADHD] Index, Hyperactivity, or Cognitive-Problems/Inattention Index of parent-completed attention deficit hyperactivity disorder (ADHD) rating scale [Conners Parent Rating Scale] and perform at least 1.0 standard deviations below the mean on Omissions, Commissions, or Variability indexes of the Test of Variables of Attention (TOVA)
Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) >55.

Exclusion Criteria:

Have optic pathway gliomas and/or neurofibromatosis
Diagnosed with ADD/ADHD prior to their cancer diagnosis
Currently taking antidepressants or antipsychotics
Currently being treated with stimulant medication
Have glaucoma
Have a family or personal history of motor or phonic tics or Tourette syndrome
Have seizures not controlled by antiepileptic drugs
Taking an MAO-inhibitor
Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives


Participant With Attention Deficit

All Events

Event Type Organ System Event Term

Effectiveness of Methylphenidate on Neurocognitive Components

Child performance on neuropsychological testing (i.e., using Test of Variables of Attention [TOVA] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder [ADHD], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores < or = 1 SD below the mean represent area of deficit.

Participant With Attention Deficit

Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior

Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function [BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form [CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores > or = 60 represent areas of significant behavior concern.

Participant With Attention Deficit

Age, Categorical

Sex: Female, Male

Overall Study

Participant With Attention Deficit

Drop/Withdrawal Reasons

Participant With Attention Deficit