Objective: To characterize the benefits and optimal dose of long-acting methylphenidate for management of long-term attention problems after childhood traumatic brain injury (TBI).
Design: Phase 2, randomized, double-masked, placebo-controlled, dose-titration, crossover clinical trial.
Setting: Outpatient, clinical research.
Participants: Twenty-six children aged 6 to 17 years who were at least 6 months post-TBI and met criteria for attention-deficit hyperactivity disorder (ADHD) at the time of enrollment.
Outcome measures: Vanderbilt Rating Scale of attention problems, Pittsburgh Side Effects Rating Scale, and vital signs.
Results: Among the 26 participants randomized, 20 completed the trial. The mean ages at injury and enrollment were 6.3 and 11.5 years, respectively. Eight participants had a severe TBI. On an optimal dose of medication, greater reductions were found on the Vanderbilt Parent Rating Scale for the medicated condition than for placebo (P = .022, effect size = 0.59). The mean optimal dose of methylphenidate was 40.5 mg (1.00 mg/kg/day). Preinjury ADHD diagnosis status was not associated with a differential medication response. Methylphenidate was associated with weight loss (∼1 kg), increased systolic blood pressure (∼3- to 6-point increase), and mild reported changes in appetite.
Conclusion: Findings support use of long-acting methylphenidate for management of long-term attention problems after pediatric TBI. Larger trials are warranted of stimulant medications, including comparative effectiveness and combination medication and nonmedication interventions.
Trial registration: ClinicalTrials.gov NCT01933217.