Trial · NCT00889915
Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)
NCT00889915, Phase 4, Completed, Duke University; results first posted 2013-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study). Trials, record NCT00889915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00889915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)
- NCT number
- NCT00889915
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 228 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Methylphenidate transdermal system, Lisdexamfetamine dimesylate, Osmotic-release oral system methylphenidate (OROS MPH), Mixed amphetamine salts extended release
- First posted
- 2009-04-29
- Last updated
- 2013-09-30
- Results first posted
- 2013-09-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale | Measured at each participant's last visit, which can occur at or before Week 6 | The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group. |
| Secondary | Clinical Global Impressions-Improvement (CGI-I) Scale | Measured at each participant's last visit, which can occur at or before Week 6 | The CGI-I score at the subject's last study visit at or before Week 6, is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-I scale will be used to rate improvement in the subject's condition (benefits) since baseline using the following 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse; 7=very much worse. |
| Secondary | Clinical Global Improvements-Acceptability (CGI-A) Scale | Measured at each participant's last visit, which can occur at or before Week 6 | The CGI-A score at the subject's last study visit at or before Week 6 is one of the 3 secondary endpoints that contribute to the primary endpoint (CGI-E). The CGI-A will be used to assess the acceptability of the study medication with respect to the subject's experience with the formulation of medication. The 7-point rating for the CGI-A will be: 1=very high acceptability, 2=high acceptability, 3=above average acceptability, 4=average acceptability, 5=low acceptability, 6=very low acceptability, 7=extremely low acceptability |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale | Measured at each participant's last visit, which can occur at or before Week 6 | Units on a scale | MEDIAN | |
| SECONDARY | Clinical Global Impressions-Improvement (CGI-I) Scale | Measured at each participant's last visit, which can occur at or before Week 6 | Units on a scale | MEDIAN | |
| SECONDARY | Clinical Global Improvements-Acceptability (CGI-A) Scale | Measured at each participant's last visit, which can occur at or before Week 6 | Units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale | Daytrana (Methylphenidate Transdermal System | 7.0 | Full Range 16.0 | Units on a scale | |
| Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale | Vyvanse (Lisdexamfetamine Dimesylate) | 5.0 | Full Range 16.0 | Units on a scale | |
| Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale | Concerta (Osmotic-release Oral System Methylphenidate) | 6.0 | Full Range 16.0 | Units on a scale | |
| Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale | Adderall (Mixed Amphetamine Salts Extended Release) | 6.0 | Full Range 16.0 | Units on a scale | |
| Clinical Global Impressions-Improvement (CGI-I) Scale | Daytrana (Methylphenidate Transdermal System | 2.0 | Full Range 1.0 to 5.0 | Units on a scale | |
| Clinical Global Impressions-Improvement (CGI-I) Scale | Vyvanse (Lisdexamfetamine Dimesylate) | 2.0 | Full Range 1.0 to 5.0 | Units on a scale | |
| Clinical Global Impressions-Improvement (CGI-I) Scale | Concerta (Osmotic-release Oral System Methylphenidate) | 2.0 | Full Range 1.0 to 7.0 | Units on a scale | |
| Clinical Global Impressions-Improvement (CGI-I) Scale | Adderall (Mixed Amphetamine Salts Extended Release) | 2.0 | Full Range 1.0 to 5.0 | Units on a scale | |
| Clinical Global Improvements-Acceptability (CGI-A) Scale | Daytrana (Methylphenidate Transdermal System | 3.0 | Full Range 1.0 to 7.0 | Units on a scale | |
| Clinical Global Improvements-Acceptability (CGI-A) Scale | Vyvanse (Lisdexamfetamine Dimesylate) | 2.0 | Full Range 1.0 to 6.0 | Units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daytrana (Methylphenidate Transdermal System | 37 | |
| Overall Study | STARTED | Vyvanse (Lisdexamfetamine Dimesylate) | 76 | |
| Overall Study | STARTED | Concerta (Osmotic-release Oral System Methylphenidate) | 67 | |
| Overall Study | STARTED | Adderall (Mixed Amphetamine Salts Extended Release) | 48 | |
| Overall Study | COMPLETED | Daytrana (Methylphenidate Transdermal System | 35 | |
| Overall Study | COMPLETED | Vyvanse (Lisdexamfetamine Dimesylate) | 71 | |
| Overall Study | COMPLETED | Concerta (Osmotic-release Oral System Methylphenidate) | 54 | |
| Overall Study | COMPLETED | Adderall (Mixed Amphetamine Salts Extended Release) | 40 | |
| Overall Study | NOT COMPLETED | Daytrana (Methylphenidate Transdermal System | 2 | |
| Overall Study | NOT COMPLETED | Vyvanse (Lisdexamfetamine Dimesylate) | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events44
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 | Irritability | Psychiatric disorders | Daytrana (Methylphenidate Transdermal System | 1 | 33 | 9 |
| other | Irritability | Psychiatric disorders | Vyvanse (Lisdexamfetamine Dimesylate) | 5 | 67 | 9 |
| other | Irritability | Psychiatric disorders | Concerta (Osmotic-release Oral System Methylphenidate) | 1 | 53 | 9 |
| other | Irritability | Psychiatric disorders | Adderall (Mixed Amphetamine Salts Extended Release) | 2 | 39 | 9 |
| other | Insomnia | Psychiatric disorders | Daytrana (Methylphenidate Transdermal System | 5 | 33 | 18 |
| other | Insomnia | Psychiatric disorders | Vyvanse (Lisdexamfetamine Dimesylate) | 6 | 67 | 18 |
| other | Insomnia | Psychiatric disorders | Concerta (Osmotic-release Oral System Methylphenidate) | 5 | 53 | 18 |
| other | Insomnia | Psychiatric disorders | Adderall (Mixed Amphetamine Salts Extended Release) | 2 | 39 | 18 |
| other | Angry or hostile mood | Psychiatric disorders | Daytrana (Methylphenidate Transdermal System | 1 | 33 | 9 |
| other | Angry or hostile mood | Psychiatric disorders | Vyvanse (Lisdexamfetamine Dimesylate) | 3 | 67 | 9 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daytrana (Methylphenidate Transdermal System | ||
| Total, all-cause mortality | Vyvanse (Lisdexamfetamine Dimesylate) | ||
| Total, all-cause mortality | Concerta (Osmotic-release Oral System Methylphenidate) | ||
| Total, all-cause mortality | Adderall (Mixed Amphetamine Salts Extended Release) | ||
| Total, other adverse events | Daytrana (Methylphenidate Transdermal System | 16 | 33 |
| Total, other adverse events | Vyvanse (Lisdexamfetamine Dimesylate) | 33 | 67 |
| Total, other adverse events | Concerta (Osmotic-release Oral System Methylphenidate) | 18 | 53 |
| Total, other adverse events | Adderall (Mixed Amphetamine Salts Extended Release) | 15 | 39 |
| Total, serious adverse events | Daytrana (Methylphenidate Transdermal System | 2 | 33 |
| Total, serious adverse events | Vyvanse (Lisdexamfetamine Dimesylate) | 0 | 67 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30MH066386 | Child and Adolescent Psychiatry Trials Network (CAPTN) | MARCH, JOHN S | DUKE UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2003 to 2007 |
Source NIH RePORTER
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/NCT00889915
GET https://conductscience.org/api/trials/v1/NCT00889915/events?page=2