Trial · NCT00191945
Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00191945, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00191945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00191945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT00191945
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 151 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Atomoxetine Hydrochloride, placebo
- First posted
- 2005-09-19
- Last updated
- 2010-02-02
- Results first posted
- 2010-01-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint | Week 12 | 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 | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks | Week 9 | 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 | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks | Week 6 | 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 | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks | Week 4 | 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 | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 | week 6 and week 12 | 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 | Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) | Baseline and 12 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 | Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) | Baseline and Open-Label Endpoint (107 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 | Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) | Baseline and Week 12 | The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81. |
| Secondary | Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) | Baseline to 12 weeks | Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=\[(Score-4.2382)\*10/0.32835\]+50. Higher scores mean improvement. |
| Secondary | Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) | Baseline | The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint | Week 12 | Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores. | units on a scale | MEAN |
| SECONDARY | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks | Week 9 | Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores. | units on a scale | MEAN |
| SECONDARY | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks | Week 6 | Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores. | units on a scale | MEAN |
| SECONDARY | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks | Week 4 | Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores. | units on a scale | MEAN |
| SECONDARY | Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 | week 6 and week 12 | Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) | Baseline and 12 weeks | Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) | Baseline and Open-Label Endpoint (107 weeks) | Intention to Treat analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) | Baseline and Week 12 | Intention to Treat analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) | Baseline to 12 weeks | Intention to Treat analysis. Last observation carried forward. | standard deviation units | MEAN |
| SECONDARY | Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) | Baseline | Intention to Treat analysis. All randomized participants who took at least one dose of study drug. | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group91
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint | Atomoxetine | 26.3 | Standard Deviation 12.7 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint | Placebo | 34.8 | Standard Deviation 12.3 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks | Atomoxetine | 27.3 | Standard Deviation 12.3 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks | Placebo | 34.4 | Standard Deviation 12.0 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks | Atomoxetine | 28.7 | Standard Deviation 12.9 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks | Placebo | 34.4 | Standard Deviation 12.0 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks | Atomoxetine | 31.2 | Standard Deviation 12.0 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks | Placebo | 35.5 | Standard Deviation 12.0 | units on a scale | |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 | Atomoxetine | Week 6 | 28.7 | Standard Deviation 12.9 | units on a scale |
| Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 | Placebo | Week 6 | 34.4 | Standard Deviation 12.0 | units on a scale |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Acute Treatment | STARTED | Atomoxetine | 100 | |
| Double-Blind Acute Treatment | STARTED | Placebo | 51 | |
| Double-Blind Acute Treatment | COMPLETED | Atomoxetine | 94 | |
| Double-Blind Acute Treatment | COMPLETED | Placebo | 48 | |
| Double-Blind Acute Treatment | NOT COMPLETED | Atomoxetine | 6 | |
| Double-Blind Acute Treatment | NOT COMPLETED | Placebo | 3 | |
| Open-Label Treatment Extension | STARTED | Atomoxetine | 94 | |
| Open-Label Treatment Extension | STARTED | Placebo | 48 | |
| Open-Label Treatment Extension | COMPLETED | Atomoxetine | 94 | |
| Open-Label Treatment Extension | COMPLETED | Placebo | 48 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events36
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 | Tachycardia | Cardiac disorders | Atomoxetine | 4 | 100 | 4 |
| other | Tachycardia | Cardiac disorders | Placebo | 3 | 51 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Atomoxetine | 17 | 100 | 20 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 4 | 51 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine | 6 | 100 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 2 | 51 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine | 4 | 100 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 51 | 3 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 5 | 100 | 7 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 51 | 2 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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 | 80 | 100 |
| Total, other adverse events | Placebo | 38 | 51 |
| Total, serious adverse events | Atomoxetine | 0 | 100 |
| Total, serious adverse events | Placebo | 1 | 51 |
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.
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