Traumatic Brain Injury-Related Attention Deficits in Children: A Controlled Treatment Trial with Lisdexamfetamine Dimesylate (Vyvanse).

Attention deficits are among the most common and persistent impairments resulting from traumatic brain injury (TBI). This study was the first to examine the effects of lisdexamfetamine dimesylate (LDX, Vyvanse) in treating TBI-related attention deficits in children. It was an extension of a previous controlled trial with adults. This was a 12-week, randomized, double-blind, placebo-controlled, dose-titration, crossover trial. In addition to weekly safety monitoring, there were assessments on a broad range of neuropsychological and behavioral measures at baseline, 6-weeks, and 12-weeks. A total of 20 carefully selected children were enrolled, ranging from 10 to 16 years of age. The sample consisted of cases with mainly mild TBI (based on the known details regarding their injuries), but they had persisting attention deficits and other post-concussion symptoms lasting from 2 to 29 months by the time of enrollment. A total of 16 children completed the trial. One of the children withdrew due to a mild anxiety reaction while on LDX. There were no other adverse effects. Positive treatment results were found on both formal testing of sustained attention and in terms of parent ratings of attention, emotional status, behavioral controls, and various aspects of executive functioning. The findings also served to highlight broader insights into the nature of attention deficits and their treatment in children with TBI.

RCT Entities:   Population Interventions Outcomes