Trial · NCT00801229
Effect of Vyvanse on Driving in Young Adults With ADHD
NCT00801229, Phase 4, Completed, Massachusetts General Hospital; results first posted 2011-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Vyvanse on Driving in Young Adults With ADHD. Trials, record NCT00801229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00801229
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Vyvanse on Driving in Young Adults With ADHD
- NCT number
- NCT00801229
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 75 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Attention Deficit/Hyperactivity Disorder(ADHD)
- Interventions
- Vyvanse, Placebo
- First posted
- 2008-12-03
- Last updated
- 2014-03-10
- Results first posted
- 2011-08-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Experiencing Collisions During "Surprise Events" in Driving Simulator | 6 weeks | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Experiencing Collisions During Surprise Events in Driving Simulator | 6 weeks | Participants who completed the protocol, including endpoint Driving Simulation assessment, were analyzed (61 in total). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Experiencing Collisions During Surprise Events in Driving Simulator | Vyvanse | 8 | participants | ||
| Participants Experiencing Collisions During Surprise Events in Driving Simulator | Placebo | 17 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Signed Consent | STARTED | Vyvanse | 38 | |
| Signed Consent | STARTED | Placebo | 37 | |
| Signed Consent | COMPLETED | Vyvanse | 35 | |
| Signed Consent | COMPLETED | Placebo | 34 | |
| Signed Consent | NOT COMPLETED | Vyvanse | 3 | |
| Signed Consent | NOT COMPLETED | Placebo | 3 | |
| Received Study Drug/Placebo | STARTED | Vyvanse | 35 | |
| Received Study Drug/Placebo | STARTED | Placebo | 34 | |
| Received Study Drug/Placebo | COMPLETED | Vyvanse | 31 | |
| Received Study Drug/Placebo | COMPLETED | Placebo | 30 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Decreased Appetite | Metabolism and nutrition disorders | Vyvanse | 19 | 35 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Placebo | 2 | 34 | |
| other | Mucosal Dryness | General disorders | Vyvanse | 9 | 35 | |
| other | Mucosal Dryness | General disorders | Placebo | 1 | 34 | |
| other | Tense/Jittery | General disorders | Vyvanse | 8 | 35 | |
| other | Tense/Jittery | General disorders | Placebo | 2 | 34 | |
| other | Insomnia | General disorders | Vyvanse | 7 | 35 | |
| other | Insomnia | General disorders | Placebo | 1 | 34 | |
| other | Headaches | General disorders | Vyvanse | 5 | 35 | |
| other | Headaches | General disorders | Placebo | 1 | 34 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vyvanse | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vyvanse | 30 | 35 |
| Total, other adverse events | Placebo | 20 | 34 |
| Total, serious adverse events | Vyvanse | 0 | 35 |
| Total, serious adverse events | Placebo | 0 | 34 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23174471 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vyvanse vs Placebo: Participants Experiencing Collisions During Surprise Events in Driving Simulator | Trial comparisons |
| Vyvanse vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00801229
GET https://conductscience.org/api/trials/v1/NCT00801229/events?page=2