TriangleNCT01100658 · REGISTRY CONDITION SEARCH
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- NA
- Status at capture
- TERMINATED
- Registry last update
- 2015-03-27
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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 * Blind * 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
- healthy Volunteers
- false
- maximum Age
- 17 Years
- minimum Age
- 8 Years
- sex
- ALL
- std Ages
- CHILD
Treatment arms and interventions
- arm Groups
- description
- Administered 1 capsule each day for 1 week, .3 mg/kg dose.
- intervention Names
- Drug: Methylphenidate
- label
- Methylphenidate
- type
- ACTIVE_COMPARATOR
- description
- Administered 1 capsule each day for 1 week.
- intervention Names
- Drug: Placebo
- label
- Placebo
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Methylphenidate
- description
- 1 capsule each day for 1 week, .3 mg/kg dose.
- name
- Methylphenidate
- other Names
- Metadae CD (TM)
- Methylphenidate hydrochloride
- type
- DRUG
- arm Group Labels
- Placebo
- description
- 1 capsule per day for 1 week.
- name
- Placebo
- other Names
- Inactive substance
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- CROSSOVER
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 1
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Effectiveness of Methylphenidate on Neurocognitive Components
- time Frame
- Week 1 and Week 2
- secondary Outcomes
- description
- 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.
- measure
- Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior
- time Frame
- Week 1 and Week 2
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- query cond
- Primary Central Nervous System Lymphoma
- query disease state id
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- source file
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Preserved source evidence · Not medical advice