Phase 4
N=26
Methylphenidate for Attention Problems After Pediatric TBI
Traumatic Brain Injury · TBI · ADHD
Bottom Line
View on ClinicalTrials.gov: NCT01933217 ↗Enrolled (actual)
26
Serious AEs
2.5%
Results posted
Jun 2020
Primary outcome: Primary: Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS) — 1.10; 1.47; .84; 1.14 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylphenidate (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS) |
1.10; 1.47; .84; 1.14; 1.37; 1.79 | — |
| PRIMARY Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF) |
60.05; 65.20; 54.30; 58.00; 62.40; 67.75 | — |
| SECONDARY Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI) |
96.05; 91.25 | — |
| SECONDARY Teacher Outcome Measure |
— | — |
Summary
Traumatic Brain Injury (TBI) - methylphenidate treatment
Eligibility Criteria
Inclusion Criteria
- Between ages of 6-17
- Sustained Moderate to Severe TBI
- TBI occurred at least 6 months prior to beginning the study
- TBI occurred no earlier than 5 years of age
- Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale
Exclusion Criteria
- History of developmental disability or mental retardation
- Current active participation in ADHD-related behavioral intervention
- History of psychiatric condition requiring an inpatient admission in past 12 months
- Actively taking medications with a contraindication to Concerta that cannot be discontinued
- Current use of stimulant medication or ADHD specific medications that cannot be discontinued
- Non-blunt head injury
- Family history of arrhythmia
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01933217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.