Trial · NCT00320528
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT00320528, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00320528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00320528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT00320528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 269 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- atomoxetine
- First posted
- 2006-05-03
- Last updated
- 2010-01-06
- Results first posted
- 2010-01-06
- Limitations and caveats
The original intent was to also calculate change and 95% confidence intervals at end of Period III; however, due to low number of patients completing Period III, variations from baseline (LOCF), are not suitable for further analysis or description.
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 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain | Baseline, 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. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement. |
| Secondary | Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | Baseline, 12 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: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54. |
| Secondary | Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) | Baseline, 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 | Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains | Baseline, 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 having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain. |
| Secondary | Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS) | Baseline, 12 Weeks | The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation. |
| Secondary | Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R) | Baseline, 12 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 12 Week Endpoint in SNAP-IV Oppositional Scale | Baseline, 12 Weeks | Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. 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 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4) | Baseline, 12 Weeks | Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18). |
| Secondary | Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4) | Baseline, 12 Weeks | The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18). |
| Secondary | Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S) | Baseline, 12 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. |
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 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | T-Score | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | T-Score | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS) | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R) | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4) | Baseline, 12 Weeks | Number of adolescent patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4) | Baseline, 12 Weeks | Number of child patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S) | Baseline, 12 Weeks | Number of patients with baseline and at least one nonmissing post-baseline measurement. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group198
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 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain | Pure ADHD | 2.65 | 95% Confidence Interval 0.93 to 4.37 | T-Score | |
| Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain | ADHD+Internalizing Disorders | 0.51 | 95% Confidence Interval -1.38 to 2.39 | T-Score | |
| Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain | ADHD+Externalizing Disorders | 3.89 | 95% Confidence Interval 2.22 to 5.57 | T-Score | |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | Pure ADHD | Inattention Subscale | -5.88 | 95% Confidence Interval -6.97 to -4.78 | units on a scale |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | ADHD+Internalizing Disorders | Inattention Subscale | -5.52 | 95% Confidence Interval -7.34 to -3.69 | units on a scale |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | ADHD+Externalizing Disorders | Inattention Subscale | -7.58 | 95% Confidence Interval -8.69 to -6.46 | units on a scale |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | Pure ADHD | Hyperactivity/Impulsivity Subscale | -6.19 | 95% Confidence Interval -7.25 to -5.13 | units on a scale |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | ADHD+Internalizing Disorders | Hyperactivity/Impulsivity Subscale | -5.67 | 95% Confidence Interval -7.41 to -3.92 | units on a scale |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | ADHD+Externalizing Disorders | Hyperactivity/Impulsivity Subscale | -8.08 | 95% Confidence Interval -9.09 to -7.07 | units on a scale |
| Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV) | Pure ADHD | Combined Type (ADHD) Subscale | -12.1 | 95% Confidence Interval -13.9 to -10.3 | units on a scale |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Period II | STARTED | Pure ADHD | 98 | |
| Study Period II | STARTED | ADHD+Internalizing Disorders | 41 | |
| Study Period II | STARTED | ADHD+Externalizing Disorders | 130 | |
| Study Period II | Received at Least One Dose of Study Drug | Pure ADHD | 97 | |
| Study Period II | Received at Least One Dose of Study Drug | ADHD+Internalizing Disorders | 38 | |
| Study Period II | Received at Least One Dose of Study Drug | ADHD+Externalizing Disorders | 128 | |
| Study Period II | COMPLETED | Pure ADHD | 87 | |
| Study Period II | COMPLETED | ADHD+Internalizing Disorders | 31 | |
| Study Period II | COMPLETED | ADHD+Externalizing Disorders | 108 | |
| Study Period II | NOT COMPLETED | Pure ADHD | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events72
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 | Pure ADHD | 9 | 97 | 13 |
| other | Abdominal pain | Gastrointestinal disorders | ADHD+Internalizing Disorders | 8 | 38 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | ADHD+Externalizing Disorders | 18 | 128 | 32 |
| other | Abdominal pain upper | Gastrointestinal disorders | Pure ADHD | 5 | 97 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | ADHD+Internalizing Disorders | 6 | 38 | 8 |
| other | Abdominal pain upper | Gastrointestinal disorders | ADHD+Externalizing Disorders | 12 | 128 | 17 |
| other | Constipation | Gastrointestinal disorders | Pure ADHD | 2 | 97 | 2 |
| other | Constipation | Gastrointestinal disorders | ADHD+Internalizing Disorders | 2 | 38 | 2 |
| other | Constipation | Gastrointestinal disorders | ADHD+Externalizing Disorders | 1 | 128 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Pure ADHD | 1 | 97 | 3 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pure ADHD | ||
| Total, all-cause mortality | ADHD+Internalizing Disorders | ||
| Total, all-cause mortality | ADHD+Externalizing Disorders | ||
| Total, other adverse events | Pure ADHD | 76 | 97 |
| Total, other adverse events | ADHD+Internalizing Disorders | 29 | 38 |
| Total, other adverse events | ADHD+Externalizing Disorders | 94 | 128 |
| Total, serious adverse events | Pure ADHD | 1 | 97 |
| Total, serious adverse events | ADHD+Internalizing Disorders | 0 | 38 |
| Total, serious adverse events | ADHD+Externalizing Disorders | 2 | 128 |
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/NCT00320528
GET https://conductscience.org/api/trials/v1/NCT00320528/results?page=2