Phase 4
N=75
Effect of Vyvanse on Driving in Young Adults With ADHD
Attention Deficit/Hyperactivity Disorder(ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT00801229 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Participants Experiencing Collisions During "Surprise Events" in Driving Simulator — 8; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vyvanse (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Experiencing Collisions During "Surprise Events" in Driving Simulator |
8; 17 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female outpatients, aged 18-24 years.
- Subjects meeting full criteria for the diagnosis of DSM-IV Attention Deficit Hyperactivity Disorder (ADHD), with onset of symptoms in childhood and persistence of impairing symptoms into adulthood as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
- Absence of pharmacological treatment for ADHD for the past month.
Exclusion Criteria
- Any other current psychiatric or medical condition determined to be clinically significant.
- Current use of psychotropics or any medication with clinically significant CNS effects.
- Individuals who have never held a valid driver's license.
- Mental retardation (IQ 140/90) during screening period (including screening and baseline visits), defined as two or more readings (each being the average of three measurements) at a single visit with systolic blood pressure, SBP > 140 and/or diastolic blood pressure, DBP, > 90, and confirmed by manual reading.
- Subjects with isolated incidences (of triplicate average BP) of SBP > 140 and/or DBP > 90 at baseline/week 0 visit, confirmed by manual reading, which are determined to be clinically significant.
Subjects with a clinically significant abnormality according to cardiology consultation (ECGs with clinically concerning intervals including PR, QTC, QRS, will be reviewed by cardiology).
Data sourced from ClinicalTrials.gov (NCT00801229). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.