Trial · NCT00471354
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
NCT00471354, Phase 4, Completed, Eli Lilly and Company; results first posted 2009-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine. Trials, record NCT00471354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00471354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
- NCT number
- NCT00471354
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 228 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Atomoxetine
- First posted
- 2007-05-09
- Last updated
- 2010-01-12
- Results first posted
- 2009-12-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) | Baseline, 24 weeks | Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. |
| Secondary | Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes | Baseline, 24 weeks | Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. |
| Secondary | Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Baseline, 24 weeks | Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. |
| Secondary | Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score | Baseline, 24 weeks | Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. |
| Secondary | Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S) | Baseline, 24 weeks | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). |
| Secondary | CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint | 24 weeks | Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened). |
| Secondary | Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score | Baseline, 24 weeks | A 27-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) | Baseline, 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA). | Spearman Correlation Coefficient | NUMBER |
| SECONDARY | Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes | Baseline, 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA). | Spearman Correlation Coefficient | NUMBER |
| SECONDARY | Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Baseline, 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score | Baseline, 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S) | Baseline, 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint | 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score | Baseline, 24 weeks | All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward. | units on a scale | MEAN |
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 |
|---|---|---|---|---|---|
Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) | Atomoxetine | -0.083 | Spearman Correlation Coefficient | ||
| Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes | Atomoxetine | Correlation with Language Scores | -0.086 | Spearman Correlation Coefficient | |
| Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes | Atomoxetine | Correlation with Math Scores | -0.126 | Spearman Correlation Coefficient | |
| Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes | Atomoxetine | Correlation with Science Scores | -0.058 | Spearman Correlation Coefficient | |
| Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Atomoxetine | Change from Baseline in Language Scores | 3.9 | Standard Deviation 13.35 | units on a scale |
| Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Atomoxetine | Change from Baseline in Math Scores | 4.1 | Standard Deviation 16.58 | units on a scale |
| Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Atomoxetine | Change from Baseline in Science Scores | 6.1 | Standard Deviation 14.98 | units on a scale |
| Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Atomoxetine | Change from Baseline in Total Scores | 4.7 | Standard Deviation 10.68 | units on a scale |
| Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score | Atomoxetine | -18.8 | Standard Deviation 9.27 | units on a scale | |
| Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S) | Atomoxetine | -2.1 | Standard Deviation 1.25 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine | 228 | |
| Overall Study | COMPLETED | Atomoxetine | 176 | |
| Overall Study | NOT COMPLETED | Atomoxetine | 52 |
Source ClinicalTrials.gov
Adverse events13
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 | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine | 15 | 228 | 16 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 49 | 228 | 57 |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 26 | 228 | 32 |
| other | Fatigue | General disorders | Atomoxetine | 25 | 228 | 28 |
| other | Irritability | General disorders | Atomoxetine | 20 | 228 | 24 |
| other | Nasopharyngitis | Infections and infestations | Atomoxetine | 15 | 228 | 15 |
| other | Weight decreased | Investigations | Atomoxetine | 16 | 228 | 19 |
| other | Anorexia | Metabolism and nutrition disorders | Atomoxetine | 55 | 228 | 61 |
| other | Decreased appetite | Metabolism and nutrition disorders | Atomoxetine | 74 | 228 | 91 |
| other | Dizziness | Nervous system disorders | Atomoxetine | 31 | 228 | 36 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ||
| Total, other adverse events | Atomoxetine | 175 | 228 |
| Total, serious adverse events | Atomoxetine | 1 | 228 |
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/NCT00471354
GET https://conductscience.org/api/trials/v1/NCT00471354/registered