Trial · NCT00192023
An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).
NCT00192023, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). Trials, record NCT00192023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00192023
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).
- NCT number
- NCT00192023
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 139 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder
- Interventions
- atomoxetine 0.5 mg/kg/day, placebo, atomoxetine 1.2 mg/kg/day, atomoxetine 1.2-1.4 mg/kg/day
- First posted
- 2005-09-19
- Last updated
- 2010-01-18
- Results first posted
- 2010-01-18
- Limitations and caveats
Due to the open-ended timing of the open-label period (up to 1.5 years or until commercial availability) the efficacy data from the open-label extension phase is not included except for adverse event data.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale | Visit 8 (baseline) and Visit 14 (8 weeks) | Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54. |
| Secondary | Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity | Visit 8 (baseline) and Visit 14 (8 weeks) | Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients. |
| Secondary | Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale | Visit 8 (baseline) and Visit 14 (8 weeks) | Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24. |
| Secondary | Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score | Visit 8 (baseline) and Visit 14 (8 weeks) | The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety. |
| Secondary | Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised | Visit 8 (baseline) and Visit 14 (8 weeks) | Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression. |
| Secondary | Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores | Visit 8 (baseline) and Visit 14 (8 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. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36. |
| Secondary | Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form | Visit 8 (baseline) and Visit 14 (8 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 | Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores | Visit 8 (baseline) and Visit 14 (8 weeks) | A 28-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index. |
| Other | Open-Label Phase Serious Adverse Events | Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval | Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval. |
| Other | Open-Label Phase Nonserious Adverse Events | Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval | Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval. |
Source ClinicalTrials.gov
Outcomes10
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 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e, 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints. | standard deviation units | MEAN |
| SECONDARY | Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores | Visit 8 (baseline) and Visit 14 (8 weeks) | Efficacy Population (All 139 randomized patients with at least a post-baseline value for the primary endpoint, i.e., 105 + 32 = 137 patients in total). Last Observation Carried Forward was applied. Missing data were not imputed, which generates different analysis population sizes for the different endpoints. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Open-Label Phase Serious Adverse Events | Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval | Number of patients who entered this optional open-label phase. All of the patients were dispensed drug. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Open-Label Phase Nonserious Adverse Events | Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval | Number of patients who entered this optional open-label phase. All of the patients were dispensed drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group71
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 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale | Atomoxetine | Baseline | 42.7 | Standard Deviation 6.2 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale | Placebo | Baseline | 41.5 | Standard Deviation 6.9 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale | Atomoxetine | Change to 8 Week Endpoint | -8.1 | Standard Deviation 9.2 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale | Placebo | Change to 8 Week Endpoint | -2.0 | Standard Deviation 4.7 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity | Atomoxetine | Baseline | 5.1 | Standard Deviation 0.8 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity | Placebo | Baseline | 5.1 | Standard Deviation 0.9 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity | Atomoxetine | Change to 8 Week Endpoint | -0.6 | Standard Deviation 0.7 | units on a scale |
| Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity | Placebo | Change to 8 Week Endpoint | 0.0 | Standard Deviation 0.5 | units on a scale |
| Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale | Atomoxetine | Baseline | 17.2 | Standard Deviation 3.0 | units on a scale |
| Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale | Placebo | Baseline | 17.5 | Standard Deviation 3.8 | units on a scale |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period III - Double-Blind | STARTED | Atomoxetine | 107 | |
| Period III - Double-Blind | STARTED | Placebo | 32 | |
| Period III - Double-Blind | COMPLETED | Atomoxetine | 100 | |
| Period III - Double-Blind | COMPLETED | Placebo | 32 | |
| Period III - Double-Blind | NOT COMPLETED | Atomoxetine | 7 | |
| Period III - Double-Blind | NOT COMPLETED | Placebo | 0 | |
| Period IV - Optional Open-Label | STARTED | Atomoxetine | 124 | |
| Period IV - Optional Open-Label | STARTED | Placebo | 0 | |
| Period IV - Optional Open-Label | COMPLETED | Atomoxetine | 49 | |
| Period IV - Optional Open-Label | COMPLETED | Placebo | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events26
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 | 11 | 107 | 13 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 32 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine | 9 | 107 | 11 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 4 | 32 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine | 4 | 107 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 32 | 2 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 14 | 107 | 15 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 32 | 0 |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 14 | 107 | 22 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 32 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 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 | 79 | 107 |
| Total, other adverse events | Placebo | 12 | 32 |
| Total, serious adverse events | Atomoxetine | 0 | 107 |
| Total, serious adverse events | Placebo | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25019647 | DERIVED |
Source PubMed
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/NCT00192023
GET https://conductscience.org/api/trials/v1/NCT00192023/results?page=2