ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00716274
Recruitment Status : Completed
First Posted : July 16, 2008
Results First Posted : February 7, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Attention Deficit Hyperactivity Disorder
Dyslexia
Interventions Drug: Atomoxetine
Drug: Placebo
Enrollment 110
Recruitment Details  
Pre-assignment Details Participants were randomized to either atomoxetine or placebo during study period II. Placebo participants were then assigned to atomoxetine in study period III. Atomoxetine participants were re-randomized to atomoxetine or placebo in study period III. Participants assigned to the healthy control group did not receive any study drug.
Arm/Group Title Atomoxetine Placebo ATX/ATX ATX/PLA PLA/ATX Healthy Participants
Hide Arm/Group Description Atomoxetine (ATX) 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) was administered orally once daily in the morning for 16 weeks, during study period II, (SP II). All eligible participants who received atomoxetine during study period II and completed that period were re-randomized to atomoxetine or placebo in study period III (SP III). Placebo (PLA) was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for Attention Deficit Hyperactivity Disorder (ADHD) or dyslexia. They received no treatment during the study.
Period Title: Study Period II (16-Weeks)
Started 45 44 0 0 0 21
Completed 36 35 0 0 0 19
Not Completed 9 9 0 0 0 2
Reason Not Completed
Entry Criteria Not Met             2             0             0             0             0             0
Protocol Violation             0             3             0             0             0             1
Withdrawal by Subject             1             0             0             0             0             0
Physician Decision             3             1             0             0             0             1
Parent/Caregiver Decision             3             3             0             0             0             0
Lost to Follow-up             0             2             0             0             0             0
Period Title: Study Period III (16-Weeks)
Started 0 [1] 0 [1] 18 [1] 18 [1] 35 [1] 19 [1]
Completed 0 0 16 17 32 19
Not Completed 0 0 2 1 3 0
Reason Not Completed
Withdrawal by Subject             0             0             2             0             0             0
Physician Decision             0             0             0             0             1             0
Parent Caregiver Decision             0             0             0             1             1             0
Adverse Event             0             0             0             0             1             0
[1]
Participants were assessed for maintenance of benefit after discontinuation of atomoxetine.
Arm/Group Title Atomoxetine Placebo Healthy Participants Total
Hide Arm/Group Description Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III. Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study. Total of all reporting groups
Overall Number of Baseline Participants 45 44 21 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 44 participants 21 participants 110 participants
12.2  (1.89) 12.1  (1.90) 12.4  (2.05) 12.20  (1.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 21 participants 110 participants
Female 18 17 13 48
Male 27 27 8 62
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 21 participants 110 participants
Hispanic or Latino 6 2 4 12
Not Hispanic or Latino 39 42 17 98
Unknown or Not Reported 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 44 participants 21 participants 110 participants
American Indian or Alaska Native 0 0 0 0
Asian 2 0 0 2
Native Hawaiian or Other Pacific Islander 0 0 0 0
Black or African American 4 13 5 22
White 33 29 12 74
More than one race 0 0 0 0
Unknown or Not Reported 6 2 4 12
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 45 participants 44 participants 21 participants 110 participants
45
 100.0%
44
 100.0%
21
 100.0%
110
 100.0%
1.Primary Outcome
Title Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame Baseline, 16 Weeks
Outcome Measure Data Not Reported
2.Primary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame Baseline, 16 Weeks
Outcome Measure Data Not Reported
3.Primary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With Attention Deficit Hyperactivity Disorder (ADHD) or ADHD + Dyslexia (Stroop Attention Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame Baseline, 16 Weeks
Outcome Measure Data Not Reported
4.Primary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame Baseline, 16 Weeks
Outcome Measure Data Not Reported
5.Primary Outcome
Title Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.57  (4.84) 2.92  (4.75)
6.Primary Outcome
Title Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 23 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 11 participants 14 participants
-11.04  (2.518) -7.53  (2.155)
ADHD Alone Number Analyzed 12 participants 9 participants
-13.85  (2.323) -1.63  (2.588)
7.Secondary Outcome
Title Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.81  (3.87) 2.25  (3.85)
8.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 23 22
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 11 participants 14 participants
-6.91  (4.689) -4.29  (4.128)
ADHD Alone Number Analyzed 12 participants 8 participants
-9.05  (5.515) -1.85  (6.695)
9.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a WJ III baseline and post-baseline measurement.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Letter Word Identification 0.88  (1.12) 2.77  (1.10)
Word Attack Score 0.48  (1.71) 2.53  (1.68)
Reading Vocabulary Score 1.04  (1.81) -1.73  (1.75)
Reading Fluency Score 0.13  (1.59) -1.06  (1.53)
Reading Comprehension Score 2.38  (1.81) -1.03  (1.74)
Spelling Score 0.89  (1.50) -0.36  (1.48)
Spelling of Sounds Score 3.11  (1.48) 3.59  (1.43)
Basic Reading Skills Score 0.99  (1.15) 2.13  (1.15)
Passage Comprehension 2.80  (2.03) -0.20  (1.96)
10.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a baseline and post-baseline WJ III measurement.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Reading Fluency -3.41  (2.16) 2.61  (2.06)
Reading Comprehension 2.02  (1.63) 0.80  (1.56)
Letter Word Identification 1.71  (1.75) -0.90  (1.69)
Word Attack Score 2.65  (1.13) 0.71  (1.07)
Reading Vocabulary 0.69  (1.89) 2.80  (1.77)
Spelling -1.36  (2.25) -2.59  (2.19)
Spelling of Sounds 8.42  (1.76) 5.02  (1.67)
Basic Reading Skills 2.53  (1.05) -0.21  (1.01)
Passage Comprehension Score 2.65  (1.71) -1.01  (1.65)
11.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had a baseline and post-baseline WJ III measurement.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Reading Fluency -2.70  (1.58) -4.98  (1.81)
Reading Comprehension -2.92  (2.39) -1.40  (2.77)
Letter Word Identification 2.60  (1.77) 0.46  (2.08)
Word Attack Score -1.60  (1.56) 0.08  (1.78)
Reading Vocabulary -1.15  (2.65) -1.48  (3.23)
Spelling 4.30  (1.20) 3.62  (1.39)
Spelling of Sounds 5.90  (3.51) 0.57  (4.04)
Basic Reading Skills 0.86  (1.42) 0.48  (1.65)
Passage Comprehension Score -4.10  (2.36) -1.80  (2.70)
12.Secondary Outcome
Title Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Awareness 4.01  (4.81) 2.69  (1.91)
Phonological Memory 5.62  (1.82) 0.62  (1.75)
Rapid Naming Score 0.19  (2.31) -1.00  (2.23)
13.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Awareness 4.60  (1.74) 1.35  (1.66)
Phonological Memory 2.33  (2.49) 3.43  (2.39)
Rapid Naming Score -0.71  (2.46) 0.21  (2.29)
14.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 12 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Awareness 3.66  (2.10) 7.00  (2.57)
Phonological Memory 3.70  (2.61) 3.48  (2.98)
Rapid Naming Score 2.36  (3.01) 1.63  (3.47)
15.Secondary Outcome
Title Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.24  (0.27) -0.44  (0.27)
Accuracy -0.10  (0.46) -0.72  (0.47)
Fluency -0.17  (0.42) -0.65  (0.42)
Reading Comprehension 0.89  (0.77) -0.29  (0.77)
Oral Reading Quotient 2.30  (2.69) -2.66  (2.72)
16.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 12 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate -0.59  (0.40) -0.45  (0.37)
Accuracy -1.77  (0.53) -1.02  (0.47)
Fluency -1.66  (0.34) -0.81  (0.31)
Reading Comprehension -2.46  (0.67) -1.55  (0.62)
Oral Reading Quotient -14.01  (4.10) -12.23  (3.40)
17.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 12 9
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.80  (0.42) 0.97  (0.48)
Accuracy 0.46  (0.35) -0.17  (0.40)
Fluency 0.72  (0.35) 0.94  (0.40)
Reading Comprehension -0.96  (0.59) 0.79  (0.70)
Oral Reading Quotient -0.74  (2.12) 5.63  (2.46)
18.Secondary Outcome
Title Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 14 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.21  (1.345) -0.17  (1.471)
19.Secondary Outcome
Title Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 26 28
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 13 participants 16 participants
0.59  (1.435) 1.18  (1.231)
ADHD Alone Number Analyzed 13 participants 12 participants
4.98  (1.611) 4.69  (1.844)
20.Secondary Outcome
Title Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 14 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score 0.74  (1.25) 0.94  (1.26)
Word List Matching Score 0.34  (2.15) 0.97  (2.12)
Word List Recall Score 0.61  (0.81) 0.50  (0.83)
Nonword List Recall Score -0.10  (0.68) 0.17  (0.69)
Block Recall Score 0.59  (1.23) 0.82  (1.25)
Mazes Memory Score -1.05  (1.87) -2.96  (1.91)
Listening Recall Score 1.41  (0.82) -0.52  (0.84)
Counting Recall Score 1.83  (0.85) 0.18  (0.88)
Backward Digit Recall Score -0.28  (1.52) 0.65  (1.55)
21.Secondary Outcome
Title Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 12 16
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall -0.64  (1.04) 1.03  (0.93)
Word List Matching -0.02  (1.90) -0.78  (1.72)
Word List Recall -0.78  (0.77) 0.80  (0.70)
NonWord 0.12  (0.32) 1.12  (0.29)
Block Recall -1.71  (0.83) 0.75  (0.77)
Mazes Memory Score 3.08  (1.34) -1.01  (1.22)
Listening Recall -0.48  (0.75) 2.16  (0.68)
Counting Recall -2.26  (1.36) -1.61  (1.21)
Backward Digit Recall -0.31  (0.82) 1.76  (0.74)
22.Secondary Outcome
Title Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline WMTB-C measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall 2.70  (1.76) 0.94  (1.93)
Word List Matching -0.79  (1.61) 2.03  (1.84)
Word List Recall 1.50  (1.06) 1.17  (1.18)
NonWord 1.41  (0.82) -0.13  (0.90)
Block Recall 1.03  (1.36) 0.44  (1.67)
Mazes Memory Score 2.70  (1.61) 0.16  (1.73)
Listening Recall 1.53  (1.06) 1.57  (1.18)
Counting Recall 0.31  (1.02) -1.02  (1.14)
Backward Digit Recall 1.82  (1.23) 2.15  (1.32)
23.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline BADD-A measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 14 13
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.22  (4.756) -2.82  (5.022)
24.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
Hide Description 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 REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 13 12
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.88  (1.441) -2.51  (1.492)
25.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Hide Description 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 gender, baseline score, and age.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Reading Fluency 8.96  (3.63)
Reading Comprehension 0.24  (1.56)
Letter Word Identification 2.12  (1.67)
Spelling -1.81  (2.87)
Spelling of Sounds 4.67  (4.82)
Basic Reading Skills 3.41  (1.72)
Passage Comprehension Score 2.17  (5.68)
Word Attack Score 5.37  (4.71)
Reading Vocabulary Score -2.28  (2.18)
26.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Hide Description 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 score, age, and baseline score by treatment interaction.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Letter Word Identification 2.40  (3.30)
Word Attack Score -0.78  (0.21)
Reading Vocabulary 0.71  (1.16)
Reading Fluency 2.24  (0.27)
Reading Comprehension 2.61  (1.31)
Spelling 1.29  (3.68)
Spelling of Sounds -1.79  (1.03)
Basic Reading Skills 0.70  (0.04)
Passage Comprehension Score 3.58  (2.01)
27.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Hide Description 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 score, age, and baseline score by treatment interaction.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WJ III measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Letter Word Identification -1.89  (0.39)
Word Attack Score -1.87  (1.73)
Reading Vocabulary 5.88  (3.40)
Reading Fluency 2.93  (3.82)
Reading Comprehension 4.77  (2.39)
Spelling 4.04  (2.79)
Spelling of Sounds 6.80  (2.79)
Basic Reading Skills -2.44  (0.77)
Passage Comprehension Score -3.16  (1.09)
28.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Phonological Awareness -0.41  (0.67)
Phonological Memory -4.63  (2.41)
Rapid Naming Score 3.99  (4.49)
29.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Phonological Awareness 12.69  (1.89)
Phonological Memory 3.40  (2.27)
Rapid Naming Score 4.72  (3.47)
30.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline CTOPP measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Phonological Awareness 5.90  (6.17)
Phonological Memory 5.61  (2.30)
Rapid Naming Score 2.67  (0.32)
31.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Hide Description 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 for treatment, gender, baseline, age, treatment*baseline.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.63  (0.79)
Accuracy -1.93  (0.47)
Fluency -0.66  (0.45)
Reading Comprehension -0.23  (2.86)
Oral Reading Quotient -9.53  (14.45)
32.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia
Hide Description 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 for treatment, gender, baseline, age, treatment*baseline.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.22  (0.25)
Accuracy 0.17  (0.02)
Fluency -0.28  (0.34)
Reading Comprehension -0.61  (0.31)
Oral Reading Quotient -2.23  (1.89)
33.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Hide Description 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 for treatment, gender, baseline, age, treatment*baseline.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline GORT-4 measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.05  (0.63)
Accuracy -1.44  (0.45)
Fluency -0.20  (0.22)
Reading Comprehension -0.02  (1.07)
Oral Reading Quotient -1.37  (4.86)
34.Secondary Outcome
Title Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.20  (3.04)
35.Secondary Outcome
Title Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline TOWRE measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 5 participants
2.77  (1.99)
ADHD Alone Number Analyzed 5 participants
6.75  (0.04)
36.Secondary Outcome
Title Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline WMTB-C measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score 0.47  (1.00)
Word List Matching Score 1.29  (2.62)
Word List Recall Score 0.75  (1.65)
Nonword List Recall Score -0.96  (2.45)
Block Recall Score 1.25  (2.51)
Mazes Memory Score 1.91  (3.74)
Listening Recall Score 4.15  (2.14)
Counting Recall Score -0.88  (1.39)
Backwards Digit Recall Score -0.64  (2.95)
37.Secondary Outcome
Title Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score 0.06  (0.07)
Word List Matching Score -4.12  (1.25)
Word List Recall Score 3.05  (1.51)
Nonword List Recall Score 1.78  (0.42)
Block Recall Score 0.56  (1.13)
Mazes Memory Score -0.22  (2.73)
Listening Recall Score 0.73  (3.37)
Counting Recall Score -0.55  (2.47)
Backward Digit Recall Score 0.05  (2.95)
38.Secondary Outcome
Title Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who had received atomoxetine in both phases and had evaluable baseline and post baseline WTMB-C measurements.No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score 3.75  (0.93)
Word List Matching Score -3.37  (0.37)
Word List Recall Score 1.25  (0.49)
Nonword List Recall Score 1.12  (0.60)
Block Recall Score 3.65  (3.48)
Mazes Memory Score -1.09  (1.43)
Listening Recall Score 4.24  (1.96)
Counting Recall Score -3.05  (1.67)
Backward Digit Recall Score -0.45  (0.00)
39.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-10.07  (6.70)
40.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS Mean was calculated using ANCOVA model with terms for gender, baseline score, and age.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline BADD-A measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 11
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 5 participants
-9.44  (7.43)
ADHD Alone Number Analyzed 6 participants
-9.33  (5.04)
41.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone
Hide Description 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 ANCOVA model with terms for gender, baseline score, and age.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12.60  (8.17)
42.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia
Hide Description 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 ANCOVA model with terms for gender, baseline score, and age.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received atomoxetine in both phases and had evaluable baseline and post baseline ADHDRS-IV-Parent: Inv measurements. No participants by design were on placebo for both study periods II and III.
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Overall Number of Participants Analyzed 11
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 5 participants
-12.96  (2.44)
ADHD Alone Number Analyzed 6 participants
-18.76  (5.89)
43.Secondary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame From Week 16, Up to Week 32
Outcome Measure Data Not Reported
44.Secondary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Attention Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame From Week 16, Up to 32 Weeks
Outcome Measure Data Not Reported
45.Secondary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame From Week 16, Up to Week 32
Outcome Measure Data Not Reported
46.Secondary Outcome
Title Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic Tasks)
Hide Description For this trial, Lilly contracted an academic institution to process the fMRI data. However, there are contractual delays limiting the timing, and Lilly does not have access to the processed fMRI data at this time.
Time Frame From Week 16, Up to Week 32
Outcome Measure Data Not Reported
47.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone
Hide Description 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 score, age, and baseline score by treatment interaction.
Time Frame From Week 16, Up to 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Word Attack Score 2.79  (2.68) -1.01  (2.10)
Letter Word Identification 2.92  (2.45) -4.08  (2.02)
Reading Fluency 11.03  (3.14) -1.53  (2.61)
Reading Comprehension 4.52  (2.60) -6.86  (2.16)
Spelling -2.90  (3.73) -1.72  (3.00)
Spelling of Sounds 3.33  (3.11) 0.30  (2.59)
Basic Reading Skills 2.87  (1.44) -3.80  (1.19)
Passage Comprehension Score 4.51  (3.30) -6.92  (2.74)
Reading Vocabulary Score 3.02  (2.04) -4.84  (1.78)
48.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia
Hide Description 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 score, age, and baseline score by treatment interaction.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 5 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Word Attack Score -2.65  (1.81) -2.62  (1.63)
Letter Word Identification 0.50  (3.19) -1.07  (3.00)
Reading Vocabulary Score 0.64  (2.17) -4.08  (2.08)
Reading Fluency 5.46  (2.77) 6.21  (2.84)
Reading Comprehension 0.86  (2.25) -2.49  (2.07)
Spelling 0.45  (2.46) 0.86  (2.32)
Spelling of Sounds -10.17  (3.40) -3.52  (3.23)
Basic Reading Skills -1.29  (1.06) -2.17  (1.00)
Passage Comprehension Score 0.15  (2.06) 0.52  (1.85)
49.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone
Hide Description 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 score, age, and baseline score by treatment interaction.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline WJ III measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 5 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Word Attack Score -1.56  (2.06) -0.58  (1.85)
Letter Word Identification -3.89  (4.46) -1.61  (4.01)
Reading Vocabulary Score 5.15  (5.51) -3.62  (4.26)
Reading Fluency 13.05  (2.32) 4.88  (1.11)
Reading Comprehension 3.86  (2.94) 3.26  (2.67)
Spelling 2.07  (4.66) 1.15  (3.81)
Spelling of Sounds -2.65  (3.02) 2.65  (2.90)
Basic Reading Skills -2.70  (3.56) -1.97  (3.17)
Passage Comprehension Score 6.86  (3.42) 2.31  (3.00)
50.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Phonological Awareness -1.19  (4.03) 2.06  (2.82)
Phonological Memory -6.96  (3.71) -1.76  (3.23)
Rapid Naming Score 7.24  (5.91) -2.42  (4.82)
51.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 5 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Phonological Awareness 3.54  (1.51) 5.29  (1.42)
Phonological Memory -2.65  (3.34) 0.12  (2.88)
Rapid Naming Score 2.65  (2.02) 1.21  (1.64)
52.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline CTOPP measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Phonological Awareness -0.33  (2.89) 9.67  (2.61)
Phonological Memory 3.59  (3.37) 0.84  (3.58)
Rapid Naming Score 1.53  (2.36) 3.51  (2.05)
53.Secondary Outcome
Title Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.17  (1.808) 4.17  (1.808)
54.Secondary Outcome
Title Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline TOWRE measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 10 11
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 5 participants 6 participants
3.74  (1.261) 1.38  (1.151)
ADHD Alone Number Analyzed 5 participants 5 participants
2.03  (4.179) 1.37  (4.179)
55.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone
Hide Description 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 for treatment, gender, baseline, age, treatment*baseline.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.27  (0.43) -0.64  (0.36)
Accuracy 0.40  (0.62) -0.69  (0.48)
Fluency 0.52  (0.67) -0.64  (0.49)
Reading Comprehension 0.06  (1.40) -0.76  (1.20)
Oral Reading Quotient -3.04  (10.51) -4.91  (8.62)
56.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia
Hide Description 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 for treatment, gender, baseline, age, treatment*baseline.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.37  (0.73) 0.31  (0.66)
Accuracy 0.07  (0.84) 0.45  (0.68)
Fluency 0.33  (1.15) 0.52  (1.08)
Reading Comprehension 1.75  (1.42) 3.64  (1.29)
Oral Reading Quotient 7.16  (4.57) 12.92  (4.32)
57.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone
Hide Description 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 for treatment, gender, baseline, age, treatment*baseline.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had evaluable baseline and post baseline GORT-4 measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Oral Reading Rate 0.36  (0.99) -0.35  (0.70)
Accuracy -1.29  (1.00) 0.15  (0.82)
Fluency -0.54  (0.76) -0.38  (0.57)
Reading Comprehension 3.46  (1.05) -0.04  (0.75)
Oral Reading Quotient 8.27  (8.94) -3.13  (5.38)
58.Secondary Outcome
Title Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score -1.77  (1.78) 0.45  (1.48)
Word List Matching Score 3.98  (4.14) 1.84  (2.99)
Word List Recall Score -0.68  (2.56) -1.90  (2.27)
Nonword List Recall Score 2.25  (0.71) -0.40  (0.55)
Block Recall Score 1.57  (1.55) -1.73  (1.07)
Mazes Memory Score 6.90  (3.29) 1.27  (2.76)
Listening Recall Score 3.44  (1.11) -1.23  (0.95)
Counting Recall Score -2.05  (2.23) -2.21  (1.87)
Backward Digit Recall Score 2.74  (4.47) 2.49  (2.21)
59.Secondary Outcome
Title Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 5 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score -1.25  (0.63) 1.83  (0.59)
Word List Matching Score -4.48  (1.74) -4.40  (1.60)
Word List Recall Score 2.34  (0.66) 2.28  (0.61)
NonWord List Recall 2.17  (1.00) 0.64  (1.57)
Block Recall Score -1.71  (2.57) 3.81  (1.89)
Mazes Memory Score -2.82  (2.69) 1.28  (2.55)
Listening Recall Score 1.93  (1.80) 0.49  (1.45)
Counting Recall Score 1.34  (2.52) -0.89  (2.46)
Backward Recall Score 0.76  (2.03) -0.14  (1.94)
60.Secondary Outcome
Title Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone
Hide Description 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline WMTB-C measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 5 5
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Recall Score 2.56  (2.92) -0.97  (2.19)
Word List Matching Score -1.22  (3.84) -1.71  (3.48)
Word List Recall Score -1.23  (1.41) 1.71  (1.22)
NonWord List Recall -1.29  (1.02) -1.12  (0.87)
Block Recall Score -1.14  (1.96) 0.59  (1.72)
Mazes Memory Score 1.11  (2.35) -2.51  (2.00)
Listening Recall Score -1.12  (3.23) -0.09  (2.94)
Counting Recall Score -0.03  (4.53) -2.90  (3.75)
Backward Recall Score -0.68  (2.03) -0.46  (1.83)
61.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 6
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.96  (5.240) 7.13  (5.240)
62.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 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.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline BADD-A measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 10 11
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 5 participants 6 participants
-0.90  (8.646) 14.59  (7.892)
ADHD Alone Number Analyzed 5 participants 5 participants
1.01  (4.416) 3.69  (4.461)
63.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone
Hide Description 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 REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 6 18
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.02  (2.537) 0.27  (1.457)
64.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia
Hide Description 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 REML-based, MMRM analysis which includes treatment, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame From Week 16, Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and post baseline ADHDRS-IV measurements. The objectives for this portion of the trial centered around participants already exposed to ATX for 16 weeks and therefore no data for PLA/ATX are given.
Arm/Group Title ATX/ATX ATX/PLA
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 10 32
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
ADHD + Dyslexia Number Analyzed 5 participants 19 participants
-0.32  (3.991) -6.38  (1.946)
ADHD alone Number Analyzed 5 participants 13 participants
-6.29  (2.546) -8.83  (1.561)
65.Secondary Outcome
Title The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
Hide Description The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 16 15
Measure Type: Count of Participants
Unit of Measure: Participants
13 11
66.Secondary Outcome
Title The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
Hide Description The number of participants who experienced one or more TEAEs and who had ADHD and ADHD+Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
Overall Number of Participants Analyzed 28 29
Measure Type: Count of Participants
Unit of Measure: Participants
ADHD + Dyslexia Number Analyzed 15 participants 17 participants
12 14
ADHD alone Number Analyzed 13 participants 12 participants
12 8
67.Secondary Outcome
Title The Number of Participants With TEAE in Participants With Dyslexia
Hide Description The number of participants with at least one TEAE and had Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame From 16 Weeks Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title ATX/ATX ATX/PLA PLA/ATX
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 7 6 12
Measure Type: Count of Participants
Unit of Measure: Participants
3 2 8
68.Secondary Outcome
Title The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia.
Hide Description The number of participants who experienced one or more TEAEs with ADHD and ADHD + Dyslexia. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame From Week 16 Up to Week 32
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title ATX/ATX ATX/PLA PLA/ATX
Hide Arm/Group Description:
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 12 12 18
Measure Type: Count of Participants
Unit of Measure: Participants
ADHD + Dyslexia 2 2 10
ADHD Alone 3 4 8
69.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of participants who had at least one adverse event. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time Frame 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Atomoxetine Placebo ATX/ATX ATX/PLA PLA/ATX
Hide Arm/Group Description:
Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III.
Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III.
These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day..
These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
Overall Number of Participants Analyzed 45 44 18 18 35
Measure Type: Count of Participants
Unit of Measure: Participants
35 31 8 8 25
70.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline WJ III measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Letter Word Identification -3.42  (5.18)
Word Attack Score -2.74  (6.54)
Reading Vocabulary -0.63  (7.87)
Reading Fluency 5.37  (10.45)
Reading Comprehension -1.84  (6.98)
Spelling 2.21  (5.70)
Spelling of Sounds -2.16  (18.35)
Basic Reading Skills -3.58  (5.10)
Passage Comprehension -2.11  (7.89)
71.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Hide Description 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.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline CTOPP measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Awareness 3.63  (11.12)
Phonological Memory 2.05  (3.88)
Rapid Naming Score 0.63  (10.75)
72.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Hide Description 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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Oral Reading Rate 0.74  (1.52)
Accuracy 0.68  (2.60)
Fluency 0.74  (1.97)
Reading Comprehension -0.16  (2.95)
Oral Reading Quotient -3.42  (24.58)
73.Secondary Outcome
Title Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants
Hide Description 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 analyses which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline TOWRE measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.20  (1.487)
74.Secondary Outcome
Title Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Hide Description 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).
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Digit Recall Score 2.47  (4.50)
Word List Matching Score -0.95  (5.38)
Word List Recall Score 1.79  (2.53)
Nonword List Recall Score 0.58  (4.31)
Block Recall Score 1.63  (4.83)
Mazes Memory Score 1.11  (7.72)
Listening Recall Score -0.58  (3.61)
Counting Recall Score 0.37  (3.44)
Backward Digit Recall Score 2.95  (4.17)
75.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM analysis which includes the effects of diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who had evaluable baseline and post baseline BADD-A measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.42  (3.572)
76.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants
Hide Description 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 REML-based, MMRM analysis which includes diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame Baseline, 16 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.15  (1.055)
77.Secondary Outcome
Title Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had baseline and post-baseline WJ III measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Letter Word Identification -0.37  (5.45)
Word Attack Score -3.58  (7.23)
Reading Vocabulary 0.79  (7.79)
Reading Comprehension 0.47  (7.99)
Reading Fluency 7.84  (11.69)
Spelling 1.95  (4.49)
Spelling of Sounds 3.63  (18.94)
Basic Reading Skills Score -2.00  (5.35)
Passage Comprehension 0.05  (9.34)
78.Secondary Outcome
Title Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants
Hide Description 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.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline CTOPP measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Awareness 3.63  (11.12)
Phonological Memory 2.05  (3.88)
Rapid Naming Score 0.63  (10.75)
79.Secondary Outcome
Title Change From Baseline to Endpoint in GORT-4 in Healthy Participants
Hide Description 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.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline GORT-4 measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Oral Reading Rate 0.74  (1.52)
Accuracy 0.68  (2.60)
Fluency 0.74  (1.97)
Comprehension -0.16  (2.95)
Oral Reading Quotient -3.42  (24.58)
80.Secondary Outcome
Title Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants
Hide Description 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 diagnostic group, visit, and diagnostic group-by-visit interaction.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline TOWRE measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
4.05  (1.578)
81.Secondary Outcome
Title Change From Baseline to Endpoint in WMTB-C in Healthy Participants
Hide Description 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).
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline WMTB-C measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: participants
Digit Recall Score 2.47  (4.50)
Word List Matching Score -0.95  (5.38)
Word List Recall Score 1.79  (2.53)
Nonword List Recall Score 0.58  (4.31)
Block Recall Score 1.63  (4.83)
Mazes Memory Score 1.11  (7.72)
Listening Recall Score -0.58  (3.61)
Counting Recall Score 0.37  (3.44)
Backwards Digit Recall Score 2.95  (4.17)
82.Secondary Outcome
Title Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants
Hide Description 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 ADD. Scores of 0-39 equate to "ADD possible but not likely". Scores of 40-54 equate to "ADD probable but not certain". Scores of 55-120 equate to "ADD highly probable". LS mean was calculated using a REML-based, MMRM which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline BADD-A measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
5.74  (3.991)
83.Secondary Outcome
Title Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants
Hide Description 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 REML-based, MMRM analysis which includes the effects of diagnostic group, visit, diagnostic group-by-visit interaction.
Time Frame Baseline, 32 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All healthy participants who had evaluable baseline and post baseline ADHDRS-IV measurements.
Arm/Group Title Healthy Participants
Hide Arm/Group Description:
Healthy Participants: Participants were evaluated to confirm that they did not meet criteria for ADHD or dyslexia. They received no treatment during the study.
Overall Number of Participants Analyzed 19
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.17  (1.046)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population includes all randomized participants who received one dose of study drug. Healthy participants did not receive any drug.
 
Arm/Group Title Atomoxetine Placebo ATX/ATX ATX/PLA PLA/ATX
Hide Arm/Group Description Atomoxetine 1.0 to 1.4 mg/kg was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III. Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. These participants were randomized to atomoxetine in SP II and were re-randomized to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. These participants were randomized to atomoxetine in SP II and were re-randomized to placebo in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day. These participants were randomized to placebo in SP II and were assigned to atomoxetine in SP III. Atomoxetine was dosed orally once-daily in the morning 0.5 mg/kg/day for 3 days and then titrated up to a dose between 1.2 and 1.4 mg/kg/day.
All-Cause Mortality
Atomoxetine Placebo ATX/ATX ATX/PLA PLA/ATX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine Placebo ATX/ATX ATX/PLA PLA/ATX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events