Trial · NCT00447278
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
NCT00447278, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-04-20
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents. Trials, record NCT00447278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00447278
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
- NCT number
- NCT00447278
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 399 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Atomoxetine, Other standard therapy for ADHD
- First posted
- 2007-03-14
- Last updated
- 2010-04-27
- Results first posted
- 2010-04-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | Baseline, 6 months | CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. |
| Secondary | Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | Baseline, 4 months, 12 months | CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. |
| Secondary | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance) | Baseline, 4 months, 6 months, 12 months | CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. |
| Secondary | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) | Baseline, 4 months, 6 months, 12 months | The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0="never or not at all", 1="sometimes or somewhat", 2="often or much", 3="very often or very much"). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst). |
| Secondary | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv) | Baseline, 4 months, 6 months, 12 months | Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) 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. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms. |
| Secondary | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S) | Baseline, 4 months, 6 months, 12 months | 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 | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years) | Baseline, 4 months, 6 months, 12 months | CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. |
| Secondary | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years) | Baseline, 4 months, 6 months, 12 months | CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health. |
| Secondary | Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores | Baseline, 6 months | Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | Baseline, 6 months | Number of participants who received at least one dose of study drug and did not have a missing value. Results for Last Observation Carried Forward (LOCF) are included. | T-Scores of units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | Baseline, 4 months, 12 months | Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change. | T-Scores of units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance) | Baseline, 4 months, 6 months, 12 months | Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change. | T-Scores of units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) | Baseline, 4 months, 6 months, 12 months | Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv) | Baseline, 4 months, 6 months, 12 months | Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S) | Baseline, 4 months, 6 months, 12 months | Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years) | Baseline, 4 months, 6 months, 12 months | Number of child participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 112, OEST n=124). Their data at 6 months was taken as baseline for the 12 month change. | T-Scores of units on a scale | MEAN |
| SECONDARY | Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years) | Baseline, 4 months, 6 months, 12 months | Number of adolescent participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n=27, OEST n=31). Their data at 6 months was taken as baseline for the 12 month change. | T-Scores of units on a scale | MEAN |
| SECONDARY | Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores | Baseline, 6 months | All randomized participants who received at least one dose of study drug and had non-missing values. | correlation coefficient | NUMBER |
Source ClinicalTrials.gov
Results by group277
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | Atomoxetine | Baseline (n=198, n=199) | 28.0 | Standard Deviation 12.04 | T-Scores of units on a scale |
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | OEST | Baseline (n=198, n=199) | 28.3 | Standard Deviation 12.28 | T-Scores of units on a scale |
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | Atomoxetine | Change from Baseline at 6 Months (n=150, n=166) | 8.4 | Standard Deviation 10.15 | T-Scores of units on a scale |
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | OEST | Change from Baseline at 6 Months (n=150, n=166) | 12.4 | Standard Deviation 11.37 | T-Scores of units on a scale |
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | Atomoxetine | Change from Baseline: 6 Month LOCF (n=192,n=195) | 7.3 | Standard Deviation 10.71 | T-Scores of units on a scale |
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | OEST | Change from Baseline: 6 Month LOCF (n=192,n=195) | 11.7 | Standard Deviation 11.24 | T-Scores of units on a scale |
| Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | Atomoxetine | Change from Baseline: 4 Month LOCF (n=192, n=195) | 7.8 | Standard Deviation 10.84 | T-Scores of units on a scale |
| Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | OEST | Change from Baseline: 4 Month LOCF (n=192, n=195) | 10.7 | Standard Deviation 11.32 | T-Scores of units on a scale |
| Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | Atomoxetine | Month 6 Baseline (M6B) (n=132, n=148) | 37.7 | Standard Deviation 11.75 | T-Scores of units on a scale |
| Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | OEST | Month 6 Baseline (M6B) (n=132, n=148) | 41.2 | Standard Deviation 12.28 | T-Scores of units on a scale |
1 to 10 of 277Source ClinicalTrials.gov
See all 277 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period II (6 Month Open-Label) | STARTED | Atomoxetine | 199 | |
| Period II (6 Month Open-Label) | STARTED | OEST | 200 | |
| Period II (6 Month Open-Label) | Received at Least One Dose of Study Drug | Atomoxetine | 199 | |
| Period II (6 Month Open-Label) | Received at Least One Dose of Study Drug | OEST | 199 | |
| Period II (6 Month Open-Label) | COMPLETED | Atomoxetine | 157 | |
| Period II (6 Month Open-Label) | COMPLETED | OEST | 171 | |
| Period II (6 Month Open-Label) | NOT COMPLETED | Atomoxetine | 42 | |
| Period II (6 Month Open-Label) | NOT COMPLETED | OEST | 29 | |
| Period III (Optional 6 Month Extension) | STARTED | Atomoxetine | 139 | |
| Period III (Optional 6 Month Extension) | STARTED | OEST | 155 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events40
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 | Gastrointestinal disorders | Atomoxetine | 29 | 199 | 40 |
| other | Abdominal pain | Gastrointestinal disorders | OEST | 22 | 199 | 27 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine | 18 | 199 | 21 |
| other | Abdominal pain upper | Gastrointestinal disorders | OEST | 13 | 199 | 13 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 25 | 199 | 25 |
| other | Nausea | Gastrointestinal disorders | OEST | 14 | 199 | 14 |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 21 | 199 | 25 |
| other | Vomiting | Gastrointestinal disorders | OEST | 11 | 199 | 11 |
| other | Fatigue | General disorders | Atomoxetine | 23 | 199 | 24 |
| other | Fatigue | General disorders | OEST | 5 | 199 | 5 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 | OEST | ||
| Total, other adverse events | Atomoxetine | 150 | 199 |
| Total, other adverse events | OEST | 146 | 199 |
| Total, serious adverse events | Atomoxetine | 2 | 199 |
| Total, serious adverse events | OEST | 2 | 199 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atomoxetine vs OEST: 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/NCT00447278
GET https://conductscience.org/api/trials/v1/NCT00447278/results?page=2