Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00801229 · ClinicalTrials.gov registry record · Phase 4
Effect of Vyvanse on Driving in Young Adults With ADHD
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
NCT00801229: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT00801229 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 75 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00801229, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Vyvanse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
What the finished NCT00801229 record still lists
NCT00801229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00801229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00801229 about?
NCT00801229 is a clinical study titled "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 spe...
What is the current status of trial NCT00801229?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2008-12. Estimated completion is 2010-07.
What interventions are being tested in trial NCT00801229?
The interventions under investigation include: Placebo (DRUG), Vyvanse (DRUG).
Who is sponsoring clinical trial NCT00801229?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00801229's enrollment target sits among peer trials
75 1002nd of 2000 higher than 974 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01535430 · 75 participants
Assessment of Eloquent Function in Brain Tumor Patients
- NCT01542879 · 75 participants · Phase 1
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
- NCT02232191 · 75 participants · Phase 2
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
- NCT02754544 · 75 participants · NA
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia