Trial · NCT00573534
Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse
NCT00573534, Phase 4, Completed, New York State Psychiatric Institute; results first posted 2011-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse. Trials, record NCT00573534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00573534
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Vyvanse™ In ADHD Adolescents at Risk for Substance Abuse
- NCT number
- NCT00573534
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 8 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Vyvanse
- First posted
- 2007-12-14
- Last updated
- 2017-02-20
- Results first posted
- 2011-11-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit | up to 24 weeks | The outcome is the number of subjects who achieved a clinically meaningful reduction in ADHD symptoms. This is defined as a 70% reduction from baseline as measured by change in the ADHD Rating Scale (ADHD-RS). The ADHD RS quantifies symptoms on a 0-3 scale, 0 meaning never present, 1 sometimes, 2 often present, 3 very often present. For this study, the scale was clinician administered using both parent and adolescent to achieve a consensus score, or a best estimate on the clinician's part when consensus could not be achieved |
| Secondary | Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology. | up to 24 weeks | This outcome measure integrates data from self report supplied in the Time Line Follow Back (a self report summary of all substance and alcohol use over the previous week or month) with evidence from periodic (weekly to monthly) urine toxicologies. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit | up to 24 weeks | All patients who agreed to participate. Last Observation Carried Forward was used final outcome. | participants | NUMBER |
| SECONDARY | Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology. | up to 24 weeks | The 8 subjects who took at least one dose of the medication and returned for follow up were included. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit | Group 1 | much improved (70 percent or more drop in ADHD-RS) | 6 | 0 | participants |
| Number of Participants With at Least 70% Reduction in ADHD Symptoms as Measured by Change in ADHD Rating Scale From First to Last Visit | Group 1 | unimproved | 2 | 0 | participants |
Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology. | Lisdexamfetamine Plus Family Therapy | none-low | 5 | 0 | participants |
Number of Participants With Low or no Substance Use During the Study vs the Number With Intermittent Use Judged by (1)Time Line Follow Back (Confidential Clinician Administered Record of Recent Substance Use) (2) Urine Toxicology. | Lisdexamfetamine Plus Family Therapy | intermittent | 3 | 0 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 8 | |
| Overall Study | COMPLETED | Group 1 | 5 | |
| Overall Study | NOT COMPLETED | Group 1 | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, other adverse events | Group 1 | 0 | 8 |
| Total, serious adverse events | Group 1 | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00573534
GET https://conductscience.org/api/trials/v1/NCT00573534/registered