NCT00801229

Effect of Vyvanse on Driving in Young Adults With ADHD

The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.

Conditions

• Attention Deficit/Hyperactivity Disorder(ADHD)

Interventions

Type	Name	Description
DRUG	Vyvanse	Vyvanse 30, 50, or 70 mg daily
DRUG	Placebo	Placebo 30, 50, 70 mg daily

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-12-03
• Last updated: 2014-03-10
• Results posted: 2011-08-25

Locations

1 site across 1 country: United States