CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
Vyvanse +1 moredrug
Likely dose
Vyvanse 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00801229
NCT00801229Phase 4Completed

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

Massachusetts General Hospital·interventional·Posted Dec 3, 2008·Updated Mar 10, 2014

In Brief

A Phase 4 clinical trial evaluating Vyvanse and Placebo for Attention Deficit/Hyperactivity Disorder(ADHD). Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2008
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.6 years ago

Interventions

Vyvansedrug

Vyvanse 30, 50, or 70 mg daily

Placebodrug

Placebo 30, 50, 70 mg daily