Trial · NCT01070394
Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
NCT01070394, Phase 4, Completed, NYU Langone Health; results first posted 2016-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse). Trials, record NCT01070394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01070394
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
- NCT number
- NCT01070394
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- LDX Treatment
- First posted
- 2010-02-18
- Last updated
- 2018-04-03
- Results first posted
- 2016-11-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) | 12 weeks | The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19. Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. A score of 0-16 means "Unlikely to have ADHD"; a score of 17-23 "Likely to Have ADHD" ; 24 or greater-Highly Likely to have ADHD |
| Secondary | Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS). | Week 0 to Week 12 | To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Scoring on the AMRS based on 38 items, each scored 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). The lowest scored units on a scale for 1 individual is 0, the highest 114. The scores reported below are Mean scores for 33 patients analyzed. |
| Secondary | Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES) | Visits 0 and 12 | The Adult ADHD Medication Smoothness of Effect Scale (AMSES) is a 6-item, frequency-based, self-report scale that was recently developed to assess the consistency and duration of effect of ADHD medication throughout the day. The AMSES compares the effectiveness of ADHD medication shortly after dosing with the effectiveness later in the day. Respondents are asked to rate how frequently the effective-ness of their medication was the same 2 hr post-dose as it was 4, 6, 8, 10, and 12 hr post-dose on a 0 to 4 scale (0 = never, 1 = rarel, 2 = sometimes, 3 = often, 4 = very often). In addition, respondents rate how frequently the delivery of their medication was consistent and smooth throughout the day on a visual analog scale ranging from 0 (never) to 100 (very often). |
| Secondary | Correlation Between AMRS (In Clinic) and ADHD-RS | Visits 0 and 12 | To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. AMRS and ADHD-RD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12. |
| Secondary | Change in Correlation Between AMRS and TASS | Visits 0 and 12 | To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented. AMRS and TASS scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12. |
| Secondary | Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist | Baseline to Week 12 | To correlate symptom rebound through a single day (assessed via the AMRS) with a self assessment of ADHD Symptoms. A Pearson's correlation coefficient will be presented. AMRS and self assessment of ADHD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12. |
| Secondary | Psychometric Validation of AMRS | Weeks 0-12 | To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients. |
| Secondary | Psychometric Validation of AMSES | Weeks 0-12 | To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS). | Week 0 to Week 12 | units on a scale | MEAN | |
| SECONDARY | Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES) | Visits 0 and 12 | units on a scale | MEAN | |
| SECONDARY | Correlation Between AMRS (In Clinic) and ADHD-RS | Visits 0 and 12 | Pearson's correlation coefficient | NUMBER | |
| SECONDARY | Change in Correlation Between AMRS and TASS | Visits 0 and 12 | Pearson's correlation coefficient | NUMBER | |
| SECONDARY | Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist | Baseline to Week 12 | Pearson's correlation coefficient | NUMBER | |
| PRIMARY | Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) | 12 weeks | units on a scale | MEAN | |
| SECONDARY | Psychometric Validation of AMRS | Weeks 0-12 | Cronbach's alpha coefficients | NUMBER | |
| SECONDARY | Psychometric Validation of AMSES | Weeks 0-12 | Cronbach's alpha coefficients | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS). | Overall Study | In Clinic | 27.99 | Standard Deviation 4.17 | units on a scale |
| Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS). | Overall Study | Evening | 26.9 | Standard Deviation 5.29 | units on a scale |
| Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES) | Overall Study | In Clinic | 1.31 | Standard Deviation 3.70 | units on a scale |
| Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES) | Overall Study | Evening | -3.34 | Standard Deviation 3.47 | units on a scale |
| Correlation Between AMRS (In Clinic) and ADHD-RS | Treatment Arm | .66 | Pearson's correlation coefficient | ||
| Change in Correlation Between AMRS and TASS | Overall Study | In Clinic | .96 | Pearson's correlation coefficient | |
| Change in Correlation Between AMRS and TASS | Overall Study | Evening | .96 | Pearson's correlation coefficient | |
| Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist | Overall Study | .83 | Pearson's correlation coefficient | ||
| Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) | Overall Study | 13.9 | Standard Deviation 2.31 | units on a scale | |
| Psychometric Validation of AMRS | Overall Study | In Clinic | .99 | Cronbach's alpha coefficients |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study: Lisdexamfetamine Treatment | 40 | |
| Overall Study | COMPLETED | Overall Study: Lisdexamfetamine Treatment | 33 | |
| Overall Study | NOT COMPLETED | Overall Study: Lisdexamfetamine Treatment | 7 |
Source ClinicalTrials.gov
Adverse events4
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 | Insomnia | General disorders | LDX Treatment | 32 | 40 | 34 |
| other | Headache | Vascular disorders | LDX Treatment | 21 | 40 | 22 |
| other | Loss of Appetite | Gastrointestinal disorders | LDX Treatment | 21 | 40 | 21 |
| other | Dry Mouth | General disorders | LDX Treatment | 17 | 40 | 17 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LDX Treatment | ||
| Total, other adverse events | LDX Treatment | 33 | 40 |
| Total, serious adverse events | LDX Treatment | 0 | 40 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT01070394
GET https://conductscience.org/api/trials/v1/NCT01070394/registered