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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Placebo
  • DRUG Vyvanse

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2008-12
Est. Completion 2010-07
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT00801229

The ClinicalTrials.gov registry entry for NCT00801229 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00801229 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.