Trial · NCT00607919
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
NCT00607919, Phase 4, Completed, Eli Lilly and Company; results first posted 2011-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia. Trials, record NCT00607919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00607919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
- NCT number
- NCT00607919
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 209 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder, Dyslexia
- Interventions
- Atomoxetine, Placebo
- First posted
- 2008-02-06
- Last updated
- 2011-12-15
- Results first posted
- 2011-12-15
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint | Baseline, 16 weeks | 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 (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. |
| Secondary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | Baseline, 16 weeks | The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. |
| Secondary | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint | Baseline, 16 weeks | The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment. |
| Secondary | Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint | Baseline, 16 weeks | The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills. |
| Secondary | Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint | Baseline, 16 weeks | The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better. |
| Secondary | Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint | Baseline, 16 weeks | The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills. |
| Secondary | Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint | Baseline, 16 weeks | The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency. |
| Secondary | Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint | Baseline, 16 weeks | WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores \[Range from 55-145\], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory). |
| Secondary | Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint | Baseline, 16 weeks | LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS. |
| Secondary | Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint | Baseline, 16 weeks | The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint | Baseline, 16 weeks | All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF). | units on a scale | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group287
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Atomoxetine | -20.01 | Standard Error 1.45 | units on a scale | |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Placebo | -12.27 | Standard Error 1.41 | units on a scale | |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Atomoxetine | Hyperactivity-Impulsivity Score | -8.23 | Standard Deviation 5.90 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Placebo | Hyperactivity-Impulsivity Score | -5.18 | Standard Deviation 6.01 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD Alone: Atomoxetine | Hyperactivity-Impulsivity Score | -6.26 | Standard Deviation 5.10 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Atomoxetine | Inattention Score | -10.64 | Standard Deviation 7.59 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Placebo | Inattention Score | -7.79 | Standard Deviation 6.52 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD Alone: Atomoxetine | Inattention Score | -10.33 | Standard Deviation 7.95 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Atomoxetine | Total Score | -18.87 | Standard Deviation 11.68 | units on a scale |
| Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint | ADHD+ Dyslexia (D): Placebo | Total Score | -12.98 | Standard Deviation 10.75 | units on a scale |
1 to 10 of 287Source ClinicalTrials.gov
See all 287 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Phase | STARTED | Atomoxetine/Atomoxetine | 120 | |
| Acute Phase | STARTED | Placebo/Atomoxetine | 89 | |
| Acute Phase | COMPLETED | Atomoxetine/Atomoxetine | 86 | |
| Acute Phase | COMPLETED | Placebo/Atomoxetine | 73 | |
| Acute Phase | NOT COMPLETED | Atomoxetine/Atomoxetine | 34 | |
| Acute Phase | NOT COMPLETED | Placebo/Atomoxetine | 16 | |
| Open-Label Phase | STARTED | Atomoxetine/Atomoxetine | 84 | |
| Open-Label Phase | STARTED | Placebo/Atomoxetine | 71 | |
| Open-Label Phase | COMPLETED | Atomoxetine/Atomoxetine | 74 | |
| Open-Label Phase | COMPLETED | Placebo/Atomoxetine | 59 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events38
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/Atomoxetine | 7 | 120 | 8 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo/Atomoxetine | 2 | 89 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine/Atomoxetine | 23 | 120 | 31 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo/Atomoxetine | 6 | 89 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Atomoxetine/Atomoxetine | 7 | 120 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo/Atomoxetine | 3 | 89 | 3 |
| other | Nausea | Gastrointestinal disorders | Atomoxetine/Atomoxetine | 34 | 120 | 42 |
| other | Nausea | Gastrointestinal disorders | Placebo/Atomoxetine | 5 | 89 | 6 |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine/Atomoxetine | 16 | 120 | 24 |
| other | Vomiting | Gastrointestinal disorders | Placebo/Atomoxetine | 8 | 89 | 9 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atomoxetine/Atomoxetine | ||
| Total, all-cause mortality | Placebo/Atomoxetine | ||
| Total, other adverse events | Atomoxetine/Atomoxetine | 108 | 120 |
| Total, other adverse events | Placebo/Atomoxetine | 71 | 89 |
| Total, serious adverse events | Atomoxetine/Atomoxetine | 1 | 120 |
| Total, serious adverse events | Placebo/Atomoxetine | 0 | 89 |
Source ClinicalTrials.gov
Papers4
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/Atomoxetine vs Placebo/Atomoxetine: 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/NCT00607919
GET https://conductscience.org/api/trials/v1/NCT00607919/registered?page=2