Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
NCT00716274, Phase 4, Completed, Eli Lilly and Company; results first posted 2018-02-07
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia | ClinicalTrials.gov |
| NCT number | NCT00716274 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 110 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Eli Lilly and Company | ClinicalTrials.gov |
| Conditions | Attention Deficit Hyperactivity Disorder, Dyslexia | ClinicalTrials.gov |
| Interventions | Atomoxetine, Placebo | ClinicalTrials.gov |
| First posted | 2008-07-16 | ClinicalTrials.gov |
| Last updated | 2022-11-04 | ClinicalTrials.gov |
| Other registries' IDs | eudract:2019-000419-98 | ClinicalTrials.gov |
| Results first posted | 2018-02-07 | ClinicalTrials.gov |
Registered outcomes 83
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Baseline, 16 Weeks | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) | ClinicalTrials.gov |
| Primary | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | Baseline, 16 Weeks | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | ClinicalTrials.gov |
| Primary | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | Baseline, 16 Weeks | Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) BOLD response (Blood-oxygen-level-dependent response) | ClinicalTrials.gov |
| Primary | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Baseline, 16 Weeks | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | ClinicalTrials.gov |
| Primary | Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia | 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). Total scores range from 0-54. Higher scores indicate higher impairment and lower scores indicate no impairment. LS mean was calculated using a restricted maximum likelihood (REML)-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | ClinicalTrials.gov |
| Primary | Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone | Baseline, 16 Weeks | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores which is a greater range of standard scores. Test 13, Word Attack, measures skill in applying phonic, structural analysis to the pronunciation of unfamiliar printed words. Each individual test scores range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. Least Square (LS) Mean was analyzed using last observation carried forward (LOCF), fixed-effects analysis of covariate (ANCOVA) models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone | Baseline, 16 Weeks | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. Basic Reading Skills is an aggregate measure of sight vocabulary, phonics, and structural analysis. It is a combination of Test 1, Letter-Word Identification, which measures the participant's word identification skills, and Test 13, Word Attack, which measures skill in applying phonic and structural analysis skills to the pronunciation of unfamiliar printed words. It is the average (arithmetic mean) of the tests 1 and 13. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | Baseline, 16 Weeks | The BADD-A is used to assess impairment in executive functions related to ADHD. These include 1) Organizing, prioritizing, and activating to work; 2) Focusing, sustaining and shifting attention to tasks; 3) Regulating alertness, sustaining effort, and processing speed; 4) Managing frustration and modulating emotions; 5) Utilizing working memory and accessing recall (Brown 2001). Scores range from 0-120. The higher the score the more severe the attention-deficit disorder (ADD). 0-39 equate to, "ADD possible but not likely". 40-54 equate to, "ADD probable but not certain". 55-120 equate to, "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone | Baseline, 16 Weeks | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia | Baseline, 16 Weeks | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone | Baseline, 16 Weeks | WJ III (Woodcock et al. 2001) has two parallel forms (A and B) alternating two batteries of tests-Standard and Extended. Standard tests (1 -12) have a broad set of scores. Extended tests (13 -22) have a more in-depth diagnostic assessment of academic strengths and weaknesses. Tests administered were 1, 2, 7, 9, 13, 17, and 20. The standard score scale is a mean (M) of 100 and a standard deviation (SD) of 15. The WJ III ACH has extended standard scores, which is a greater range of standard scores. Scores for each individual test range from 0 to over 200 where 69 and below is very low and 131 and above is very superior. Higher scores indicate better reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone | 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 and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia | 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 and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone | 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 and lower scores are poor. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone | 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. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models of with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia | 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. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | 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. Lower scores indicate poor reading skills. LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms of treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone | 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. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia | 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. The total standard score ranges from 35-165. Higher scores indicate higher reading proficiency and lower scores indicate lower reading proficiency. LS mean was calculated using a REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction. | ClinicalTrials.gov |
| Secondary | Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone | 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, Lower scores are poor) 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). LS mean was analyzed using LOCF, fixed-effects ANCOVA models with terms for treatment, gender, baseline, age, treatment\*baseline. | ClinicalTrials.gov |
Outcomes 83
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Baseline, 16 Weeks | All participants who received study drug, had Dyslexia Alone and had fMRI data. | Change-from-baseline (BOLD response) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) | Baseline, 16 Weeks | Stroop Tasks data were not collected. | ClinicalTrials.gov | ||
| PRIMARY | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) | Baseline, 16 Weeks | All participants who received study drug, had ADHD or ADHD + Dyslexia and had fMRI data. | Change-from-baseline (BOLD response) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) | Baseline, 16 Weeks | Stroop Tasks data were not collected. | ClinicalTrials.gov | ||
| PRIMARY | Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone | Baseline, 16 Weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone | Baseline, 16 Weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia | Baseline, 16 Weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone | Baseline, 16 Weeks | All randomized participants who had a WJ III baseline and post-baseline measurement. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia | Baseline, 16 Weeks | All randomized participants who had a baseline and post-baseline WJ III measurement. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone | Baseline, 16 Weeks | All randomized participants who had a baseline and post-baseline WJ III measurement. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone | Baseline, 16 weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone | Baseline, 16 Weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia | Baseline, 16 Weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone | Baseline, 16 Weeks | All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements. | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
Results by group 613
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Left Inferior Frontal Gyrus | -0.056 | Standard Deviation 0.125 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Left Inferior Frontal Gyrus | -0.033 | Standard Deviation 0.118 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Left Interior Temporal Gyrus | -0.061 | Standard Deviation 0.120 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Left Interior Temporal Gyrus | 0.010 | Standard Deviation 0.075 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Left Medial Temporal Gyrus | -0.038 | Standard Deviation 0.153 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Left Medial Temporal Gyrus | -0.006 | Standard Deviation 0.053 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Left Temporo-parietal Region | -0.073 | Standard Deviation 0.124 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Left Temporo-parietal Region | -0.037 | Standard Deviation 0.100 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Right Inferior Frontal Gyrus | 0.019 | Standard Deviation 0.156 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Right Inferior Frontal Gyrus | 0.018 | Standard Deviation 0.147 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Right Interior Temporal Gyrus | 0.002 | Standard Deviation 0.217 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Right Interior Temporal Gyrus | 0.058 | Standard Deviation 0.161 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Right Medial Temporal Gyrus | -0.014 | Standard Deviation 0.181 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Right Medial Temporal Gyrus | 0.071 | Standard Deviation 0.091 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Semantic-category: Right Temporo-parietal Region | -0.015 | Standard Deviation 0.145 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Semantic-category: Right Temporo-parietal Region | 0.076 | Standard Deviation 0.114 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Pseudoword Rhyming: Left Inferior Frontal Gyrus | 0.012 | Standard Deviation 0.200 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Pseudoword Rhyming: Left Inferior Frontal Gyrus | 0.020 | Standard Deviation 0.147 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Atomoxetine | Pseudoword Rhyming: Left Interior Temporal Gyrus | -0.062 | Standard Deviation 0.200 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
| Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) | Placebo | Pseudoword Rhyming: Left Interior Temporal Gyrus | -0.003 | Standard Deviation 0.109 | Change-from-baseline (BOLD response) | ClinicalTrials.gov |
Participant flow 36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Study Period II (16-Weeks) | STARTED | Atomoxetine | 45 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | STARTED | Placebo | 44 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | STARTED | ATX/ATX | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | STARTED | ATX/PLA | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | STARTED | PLA/ATX | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | STARTED | Healthy Participants | 21 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | COMPLETED | Atomoxetine | 36 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | COMPLETED | Placebo | 35 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | COMPLETED | ATX/ATX | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | COMPLETED | ATX/PLA | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | COMPLETED | PLA/ATX | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | COMPLETED | Healthy Participants | 19 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | NOT COMPLETED | Atomoxetine | 9 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | NOT COMPLETED | Placebo | 9 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | NOT COMPLETED | ATX/ATX | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | NOT COMPLETED | ATX/PLA | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | NOT COMPLETED | PLA/ATX | 0 | ClinicalTrials.gov | |
| Study Period II (16-Weeks) | NOT COMPLETED | Healthy Participants | 2 | ClinicalTrials.gov | |
| Study Period III (16-Weeks) | STARTED | Atomoxetine | 0 | ClinicalTrials.gov | |
| Study Period III (16-Weeks) | STARTED | Placebo | 0 | ClinicalTrials.gov |
Adverse events 195
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 | Source |
|---|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Atomoxetine | 0 | 45 | 0 | ClinicalTrials.gov |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 4 | 44 | 4 | ClinicalTrials.gov |
| other | Abdominal discomfort | Gastrointestinal disorders | ATX/ATX | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Abdominal discomfort | Gastrointestinal disorders | ATX/PLA | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Abdominal discomfort | Gastrointestinal disorders | PLA/ATX | 2 | 35 | 2 | ClinicalTrials.gov |
| other | Abdominal pain upper | Gastrointestinal disorders | Atomoxetine | 10 | 45 | 10 | ClinicalTrials.gov |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 12 | 44 | 12 | ClinicalTrials.gov |
| other | Abdominal pain upper | Gastrointestinal disorders | ATX/ATX | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Abdominal pain upper | Gastrointestinal disorders | ATX/PLA | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Abdominal pain upper | Gastrointestinal disorders | PLA/ATX | 4 | 35 | 4 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Atomoxetine | 0 | 45 | 0 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 44 | 1 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | ATX/ATX | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | ATX/PLA | 1 | 18 | 1 | ClinicalTrials.gov |
| other | Constipation | Gastrointestinal disorders | PLA/ATX | 0 | 35 | 0 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Atomoxetine | 7 | 45 | 7 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 44 | 5 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | ATX/ATX | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | ATX/PLA | 0 | 18 | 0 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | PLA/ATX | 1 | 35 | 1 | ClinicalTrials.gov |
Adverse event totals 15
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, all-cause mortality | ATX/ATX | ClinicalTrials.gov | ||
| Total, all-cause mortality | ATX/PLA | ClinicalTrials.gov | ||
| Total, all-cause mortality | PLA/ATX | ClinicalTrials.gov | ||
| Total, other adverse events | Atomoxetine | 35 | 45 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 31 | 44 | ClinicalTrials.gov |
| Total, other adverse events | ATX/ATX | 8 | 18 | ClinicalTrials.gov |
| Total, other adverse events | ATX/PLA | 8 | 18 | ClinicalTrials.gov |
| Total, other adverse events | PLA/ATX | 25 | 35 | ClinicalTrials.gov |
| Total, serious adverse events | Atomoxetine | 0 | 45 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 0 | 44 | ClinicalTrials.gov |
| Total, serious adverse events | ATX/ATX | 0 | 18 | ClinicalTrials.gov |
| Total, serious adverse events | ATX/PLA | 0 | 18 | ClinicalTrials.gov |
| Total, serious adverse events | PLA/ATX | 0 | 35 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Atomoxetine vs Placebo: The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia | Trial comparisons |
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Biological Motion Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)