Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
Overview
- Phase
- N/A
- Intervention
- Methylphenidate
- Conditions
- ALL, Childhood
- Sponsor
- University of Minnesota
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Effectiveness of Methylphenidate on Neurocognitive Components
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Methylphenidate
Administered 1 capsule each day for 1 week, .3 mg/kg dose.
Intervention: Methylphenidate
Placebo
Administered 1 capsule each day for 1 week.
Intervention: Placebo
Outcomes
Primary Outcomes
Effectiveness of Methylphenidate on Neurocognitive Components
Time Frame: Week 1 and Week 2
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.
Secondary Outcomes
- Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior(Week 1 and Week 2)