Effect of Vyvanse on Driving in Young Adults With ADHD
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.
Attention Deficit/Hyperactivity Disorder(ADHD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study|
- Participants Experiencing Collisions During "Surprise Events" in Driving Simulator [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Initial results from a one hour driving simulation in the MIT AgeLab Driving Simulator as compared to second session in the simulator following a 6-week trial on Lisdexamfetamine or placebo. During the simulation, "surprise events," designed to test the participant's attention and driving, occurred. This outcome presents the difference in number of collisions experience by individuals treated with Vyvanse or Placebo.
|Study Start Date:||December 2008|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Vyvanse
Patients may be randomzied to the active comparator arm. Participants randomized to this arm will receive 30, 50, or 70mg Vyvanse daily.
Vyvanse 30, 50, or 70 mg daily
Other Name: Lisdexamfetamine
Placebo Comparator: Placebo
Patients may be randomized to the placebo comparator arm. Those randomized to this arm will receive 30, 50, or 70mg placebo daily.
Placebo 30, 50, 70 mg daily
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|