Trial · NCT00510276
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
NCT00510276, Phase 4, Completed, Eli Lilly and Company; results first posted 2010-03-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes. Trials, record NCT00510276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00510276
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
- NCT number
- NCT00510276
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 445 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Atomoxetine hydrochloride, Placebo
- First posted
- 2007-08-01
- Last updated
- 2010-04-14
- Results first posted
- 2010-03-03
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint | Baseline, Week 12 | CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54. |
| Secondary | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score | Baseline, 12 weeks | Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. |
| Secondary | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale | Baseline, 12 weeks | Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. |
| Secondary | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale | Baseline, 12 weeks | Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. |
| Secondary | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale | Baseline, 12 weeks | Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. |
| Secondary | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale | Baseline, 12 weeks | Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. |
| Secondary | Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) | Baseline, 12 weeks | Single-item clinician rating of the clinician's assessment of the patient's severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7. |
| Secondary | Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score | Baseline, 12 weeks | 30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54. |
| Secondary | Endpoint Scores in Patient Global Impression - Improvement (PGI-I) | Baseline, 12 weeks | 7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse). |
| Secondary | Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS) | Baseline, 12 weeks | Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score | Baseline, 12 weeks | Analyzed was an intent-to-treat population. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale | Baseline, 12 weeks | Intent-to-treat population was used for analysis. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale | Baseline, 12 weeks | An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale | Baseline, 12 weeks | An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale | Baseline, 12 weeks | An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) | Baseline, 12 weeks | Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score | Baseline, 12 weeks | An intent-to-treat population was analyzed using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Endpoint Scores in Patient Global Impression - Improvement (PGI-I) | Baseline, 12 weeks | Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS) | Baseline, 12 weeks | Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI) | Baseline, 12 weeks | Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score | Atomoxetine | 15.76 | Standard Error 1.28 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score | Placebo | 10.95 | Standard Error 1.23 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale | Atomoxetine | 15.51 | Standard Error 1.60 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale | Placebo | 9.61 | Standard Error 1.54 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale | Atomoxetine | 20.92 | Standard Error 1.79 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale | Placebo | 15.18 | Standard Error 1.72 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale | Atomoxetine | 14.57 | Standard Error 1.53 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale | Placebo | 10.21 | Standard Error 1.47 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale | Atomoxetine | 9.27 | Standard Error 1.40 | units on a scale | |
| Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale | Placebo | 5.87 | Standard Error 1.33 | units on a scale |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Double-Blind Phase | STARTED | Atomoxetine | 220 | |
| Acute Double-Blind Phase | STARTED | Placebo | 225 | |
| Acute Double-Blind Phase | COMPLETED | Atomoxetine | 115 | |
| Acute Double-Blind Phase | COMPLETED | Placebo | 130 | |
| Acute Double-Blind Phase | NOT COMPLETED | Atomoxetine | 105 | |
| Acute Double-Blind Phase | NOT COMPLETED | Placebo | 95 | |
| Extension Open-Label Phase | STARTED | Atomoxetine | 111 | |
| Extension Open-Label Phase | STARTED | Placebo | 129 | |
| Extension Open-Label Phase | COMPLETED | Atomoxetine | 78 | |
| Extension Open-Label Phase | COMPLETED | Placebo | 81 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events50
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 discomfort | Gastrointestinal disorders | Atomoxetine | 6 | 220 | 6 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 2 | 225 | 2 |
| other | Constipation | Gastrointestinal disorders | Atomoxetine | 6 | 220 | 6 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 225 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine | 3 | 220 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 225 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Atomoxetine | 19 | 220 | 19 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 5 | 225 | 5 |
| other | Dyspepsia | Gastrointestinal disorders | Atomoxetine | 11 | 220 | 12 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 2 | 225 | 2 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Atomoxetine | 147 | 220 |
| Total, other adverse events | Placebo | 121 | 225 |
| Total, serious adverse events | Atomoxetine | 1 | 220 |
| Total, serious adverse events | Placebo | 1 | 225 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atomoxetine vs Placebo: serious adverse events |
Source 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/NCT00510276
GET https://conductscience.org/api/trials/v1/NCT00510276/registered?page=2