ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of ADHD With Atomoxetine in Children & Adolescents 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: NCT00607919
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : December 15, 2011
Last Update Posted : December 15, 2011
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 209

Recruitment Details  
Pre-assignment Details The study comprised a 16-week placebo-controlled, double-blind acute phase and followed by an optional 16-week open-label in which all participants were treated with Atomoxetine.
Arm/Group Title Atomoxetine/Atomoxetine Placebo/Atomoxetine
Hide Arm/Group Description

Participants were assigned to Atomoxetine treatment in both acute and open-label phase

Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Period Title: Acute Phase
Started 120 89
Completed 86 [1] 73 [1]
Not Completed 34 16
Reason Not Completed
Adverse Event             9             2
Entry Criteria Not Met             1             1
Lack of Efficacy             1             2
Lost to Follow-up             9             3
Parent/Caregiver Decision             6             4
Protocol Violation             5             1
Withdrawal by Subject             3             3
[1]
2 participants completed acute phase but did not continue into open-label.
Period Title: Open-Label Phase
Started 84 71
Completed 74 59
Not Completed 10 12
Reason Not Completed
Adverse Event             1             5
Lost to Follow-up             4             1
Protocol Violation             2             2
Withdrawal by Subject             2             2
Parent/Caregiver Decision             1             2
Arm/Group Title Atomoxetine/Atomoxetine Placebo/Atomoxetine Total
Hide Arm/Group Description

Participants were assigned to Atomoxetine treatment in both acute and open-label phase

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Total of all reporting groups
Overall Number of Baseline Participants 120 89 209
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 89 participants 209 participants
12.24  (1.72) 12.44  (1.90) 12.32  (1.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 89 participants 209 participants
Female
46
  38.3%
34
  38.2%
80
  38.3%
Male
74
  61.7%
55
  61.8%
129
  61.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 120 participants 89 participants 209 participants
African 13 11 24
Caucasian 86 66 152
East Asian 2 1 3
Hispanic 18 11 29
West Asian 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 120 participants 89 participants 209 participants
120 89 209
1.Primary Outcome
Title Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
Hide Description Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result.
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 47 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-20.01  (1.45) -12.27  (1.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ADHD+ Dyslexia (D): Atomoxetine, ADHD+ Dyslexia (D): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
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). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 62 58 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hyperactivity-Impulsivity Score -8.23  (5.90) -5.18  (6.01) -6.26  (5.10)
Inattention Score -10.64  (7.59) -7.79  (6.52) -10.33  (7.95)
Total Score -18.87  (11.68) -12.98  (10.75) -16.59  (11.31)
3.Secondary Outcome
Title Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
Hide Description The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 21 22 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hyperactivity-Impulsivity Score -2.71  (3.98) -1.99  (6.54) -0.82  (4.92)
Inattention Score -4.48  (5.17) -0.99  (5.33) -2.27  (5.24)
Total Score -7.19  (6.83) -2.98  (10.83) -3.09  (9.21)
4.Secondary Outcome
Title Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
Hide Description The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 51 55 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Basic Reading Skills (Tests 1, 13) 1.75  (6.04) 0.87  (6.75) -0.41  (7.99)
Letter-Word Identification (Test 1) 1.18  (7.20) -0.07  (6.63) -0.32  (8.04)
Passage Comprehension (Test 9) -0.92  (11.43) -1.02  (8.94) -4.50  (9.04)
Reading Comprehension (Test 9, 17) -0.08  (9.68) -1.09  (8.81) -5.00  (7.45)
Reading Fluency (Test 2) -0.24  (7.91) -0.11  (9.19) 1.36  (8.77)
Reading Vocabulary (Test 17) 0.51  (8.92) -0.16  (9.45) -3.95  (8.60)
Spelling (Test 7) -0.22  (7.32) -4.16  (12.13) -0.41  (5.68)
Spelling of Sounds (Test 20) 5.67  (16.07) 3.31  (13.49) 8.45  (19.78)
Word Attack (Test 13) 2.27  (6.75) 1.13  (9.75) -0.36  (7.88)
5.Secondary Outcome
Title Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 51 55 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
Blending Words 0.96  (1.90) 0.95  (1.97) 1.86  (1.86)
Elision 0.88  (2.18) -0.24  (2.34) 0.27  (1.91)
Memory for Digits 0.47  (2.16) 0.13  (1.76) -0.50  (1.90)
Non-word Repetition 0.57  (1.79) 0.51  (2.00) 0.82  (2.52)
Phonological Awareness 5.20  (9.49) 2.00  (9.34) 6.82  (11.50)
Phonological Memory 2.22  (10.61) 0.96  (10.16) 1.36  (11.33)
Rapid Digit Naming 0.26  (2.06) 0.16  (1.75) 0.23  (1.23)
Rapid Letter Naming 0.31  (1.76) 0.24  (1.64) 0.14  (1.52)
Rapid Naming 1.06  (11.00) 0.35  (9.75) -0.59  (10.83)
6.Secondary Outcome
Title Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
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.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 51 55 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Accuracy Score 0.71  (2.22) 0.40  (2.02) 0.95  (2.16)
Comprehension Score 0.37  (2.35) 0.65  (2.50) -0.33  (1.93)
Fluency Score 0.78  (2.81) 0.33  (2.82) 1.14  (2.94)
Oral Reading Quotient -1.43  (23.34) 2.87  (20.43) 2.43  (10.93)
Rate Score 0.20  (1.65) 0.05  (1.54) 0.38  (2.27)
7.Secondary Outcome
Title Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
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. Scores range from 45-146. Higher scores indicate higher reading proficiency.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 61 57 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonemic Decoding Efficiency 1.92  (6.01) 1.21  (5.19) 1.77  (6.78)
Sight Word Efficiency 1.38  (5.78) 1.19  (4.80) 0.69  (8.84)
Total Word Reading Efficiency Standard Score -0.57  (21.98) 2.81  (11.90) -5.88  (25.98)
8.Secondary Outcome
Title Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
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) 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 randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 54 56 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Loop Component Score (n=51, 54, 21) 3.57  (10.79) 1.63  (9.00) 2.24  (9.78)
Central Executive Component Score (n=41, 44,12) 7.34  (10.65) -0.89  (13.65) 2.17  (11.77)
Visuo-Spatial Sketchpad Score (n=47, 43, 21) 4.15  (11.96) -0.47  (12.85) 3.67  (10.77)
Digit Recall (n=54, 56, 23) 0.17  (3.42) 0.55  (3.01) 0.22  (4.45)
Word List Matching (n=54, 56, 23) -0.20  (7.08) 0.05  (8.65) 2.04  (9.24)
Word List Recall (n=54, 56, 23) 1.00  (3.29) 0.02  (3.15) 0.35  (2.98)
Non-Word List Recall (n=53, 56, 23) 0.89  (2.74) 0.71  (2.20) 0.43  (3.53)
Block Recall (n=54, 56, 23) -0.37  (4.20) -0.80  (4.18) 0.70  (4.24)
Mazes Memory (n=54, 56, 23) 1.94  (5.90) 1.18  (5.94) 0.78  (7.33)
Listening Recall (n=54, 56, 23) 1.52  (3.32) 1.00  (3.77) 0.04  (5.90)
Counting Recall (n=54, 56, 23) 0.50  (4.63) 0.45  (5.07) 0.48  (5.41)
Backward Digit Recall (n=54, 56, 23) 1.30  (3.87) 0.16  (3.62) 1.26  (4.20)
9.Secondary Outcome
Title Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
Hide Description LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 58 57 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
LPS Happy/Social Score 0.57  (4.19) 0.53  (4.80) 1.38  (3.73)
LPS Self Control Score 6.06  (8.54) 4.29  (10.60) 7.49  (8.46)
LPS Total Score 6.51  (11.61) 4.82  (14.20) 9.05  (10.63)
10.Secondary Outcome
Title Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
Hide Description The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 56 57 23
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total Score-Parent Variation (n= 56, 57, 23) -7.82  (10.98) -4.64  (9.67) -8.24  (9.90)
Total Score-Teacher Variation (n= 22, 22, 11) -8.82  (11.77) -1.64  (6.53) -3.47  (8.83)
Total Score-Youth Variation (n= 56, 57, 23) -4.71  (9.27) -4.21  (6.85) -6.17  (7.71)
11.Secondary Outcome
Title Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
Hide Description The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).
Time Frame Baseline, 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD+ Dyslexia (D): Placebo ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 58 57 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
Academic Standard Section Score 5.91  (9.01) 4.23  (12.77) 5.52  (6.78)
Affect Standard Section Score 3.62  (10.32) 2.35  (10.81) 3.56  (10.58)
Competence Standard Section Score 6.64  (12.99) 4.95  (12.05) 5.20  (9.06)
Family Standard Section Score 0.39  (12.52) -3.12  (11.66) -1.00  (12.26)
Physical Standard Section Score 4.09  (10.34) 1.32  (12.06) 3.04  (5.99)
Social Standard Section Score 4.36  (11.73) 2.72  (11.14) 3.88  (10.39)
Standard Total Score 4.72  (9.47) 1.98  (10.19) 3.44  (7.70)
12.Secondary Outcome
Title Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
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). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Hyperactivity-Impulsivity Score -9.8  (6.17) -8.29  (4.61)
Inattention Score -13.84  (6.56) -14.33  (7.16)
Total Score -23.64  (10.43) -22.62  (9.07)
13.Secondary Outcome
Title Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
Hide Description The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 23 9
Mean (Standard Deviation)
Unit of Measure: units
Hyperactivity-Impulsivity Score -1.87  (4.80) -2.89  (4.48)
Inattention Score -4.28  (6.08) -4.19  (4.11)
Total Score -6.15  (8.51) -7.08  (7.34)
14.Secondary Outcome
Title Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
Hide Description The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Basic Reading Skills (Tests 1, 13 2.73  (6.51) -0.24  (5.37)
Letter-Word Identification (Test 1) 1.69  (7.19) 0.24  (5.73)
Passage Comprehension (Test 9) 2.31  (9.18) 1.24  (5.63)
Reading Comprehension (Tests 9, 17) 2.89  (9.07) 0.86  (7.04)
Reading Fluency (Test 2) 2.69  (9.04) 3.24  (8.64)
Reading Vocabulary (Test 17) 2.60  (8.55) -0.14  (10.57)
Spelling (Test 7) 0.60  (7.74) 0.38  (5.96)
Spelling of Sounds (Test 20) 2.98  (10.77) 5.90  (14.17)
Word Attack (Test 13) 3.27  (7.09) -0.90  (6.59)
15.Secondary Outcome
Title Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
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.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Blending Words 1.31  (2.01) 1.90  (2.98)
Elision 1.07  (2.00) 0.71  (3.05)
Memory for Digits 0.87  (2.17) -0.05  (2.13)
Non-word Repetition 0.93  (2.27) 0.43  (3.03)
Phonological Awareness 7.33  (9.50) 5.33  (15.99)
Phonological Memory 4.93  (10.57) -0.67  (12.44)
Rapid Digit Naming 0.43  (1.91) 0.62  (2.31)
Rapid Letter Naming 0.43  (2.06) 0.90  (2.34)
Rapid Naming 1.30  (11.27) 1.76  (12.35)
16.Secondary Outcome
Title Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
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.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Accuracy Score 0.82  (1.30) 0.95  (1.82)
Comprehension Score 0.04  (1.73) -0.30  (1.59)
Fluency Score 0.76  (1.40) 1.10  (2.63)
Oral Reading Quotient 2.64  (15.05) -1.30  (21.22)
Rate Score 0.58  (1.74) 0.15  (1.98)
17.Secondary Outcome
Title Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
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. Scores range from 45-146. Higher scores indicate higher reading proficiency.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonemic Decoding Efficiency 2.64  (6.54) 5.33  (6.98)
Sight Word Efficiency 1.93  (6.51) 4.62  (8.74)
Total Word Reading Efficiency Standard Score 2.56  (17.35) 1.52  (20.64)
18.Secondary Outcome
Title Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
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) 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 randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Phonological Loop Component Score (n=43, 20) 3.67  (11.27) 1.70  (9.66)
Central Executive Component Score (n=38, 14) 6.53  (11.34) 1.64  (11.30)
Visuo-Spatial Sketchpad Component Score (n=40, 20) 3.85  (12.89) 2.65  (9.96)
Digit Recall (n=45, 21) -0.04  (2.92) 0.52  (4.08)
Word List Matching (n=45, 21) 2.38  (7.96) 1.95  (8.22)
Word List Recall (n=45, 21) 1.49  (3.00) 0.33  (2.50)
Non-Word List Recall (n=44, 21) 0.55  (2.90) -0.67  (4.39)
Block Recall (n=45, 21) 0.71  (3.88) 1.05  (4.24)
Mazes Memory (n=45, 21) 2.33  (7.04) 3.48  (7.77)
Listening Recall (n=45, 21) 2.18  (4.01) -1.05  (6.42)
Counting Recall (n=45, 21) 1.53  (4.65) 1.24  (6.54)
Backward Digit Recall (n=45, 21) 1.07  (3.24) 2.29  (5.20)
19.Secondary Outcome
Title Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
Hide Description LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
LPS Happy/Social Score (n=45, 21) 1.57  (4.37) 2.14  (4.30)
LPS Self Control Score (n=45, 20) 9.10  (10.73) 10.44  (10.42)
LPS Total Score (n=45, 20) 10.67  (14.27) 12.64  (13.95)
20.Secondary Outcome
Title Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
Hide Description The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total Score-Parent Variation (n=45, 21) -10.40  (11.94) -10.83  (10.84)
Total Score-Teacher Variation (n=23, 9) -7.00  (12.82) -7.89  (5.18)
Total Score-Youth Variation (n=45, 21) -4.36  (7.57) -5.43  (8.44)
21.Secondary Outcome
Title Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
Hide Description The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).
Time Frame Baseline, 32 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who entered open-label phase with a baseline and at least one post-baseline result, and last observation carried forward (LOCF).
Arm/Group Title ADHD+ Dyslexia (D): Atomoxetine ADHD Alone: Atomoxetine
Hide Arm/Group Description:

Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

Overall Number of Participants Analyzed 45 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
Academic Standard Section Score 6.02  (9.72) 5.43  (6.98)
Affect Standard Section Score 4.29  (11.14) 3.14  (10.45)
Competence Standard Section Score 6.76  (11.77) 5.19  (7.94)
Family Standard Section Score 0.16  (14.40) 0.33  (9.79)
Physical Standard Section Score 6.09  (12.00) 2.43  (7.20)
Social Standard Section Score 4.84  (11.84) 2.38  (11.75)
Standard Total Score 5.61  (10.82) 3.48  (7.21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine/Atomoxetine Placebo/Atomoxetine
Hide Arm/Group Description

Participants were assigned to Atomoxetine treatment in both acute and open-label phase

Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine

Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.

Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine

All-Cause Mortality
Atomoxetine/Atomoxetine Placebo/Atomoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine/Atomoxetine Placebo/Atomoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/120 (0.83%)      0/89 (0.00%)    
Infections and infestations     
Wound infection staphylococcal  1  1/120 (0.83%)  1 0/89 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atomoxetine/Atomoxetine Placebo/Atomoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   108/120 (90.00%)      71/89 (79.78%)    
Gastrointestinal disorders     
Abdominal discomfort  1  7/120 (5.83%)  8 2/89 (2.25%)  2
Abdominal pain upper  1  23/120 (19.17%)  31 6/89 (6.74%)  8
Diarrhoea  1  7/120 (5.83%)  7 3/89 (3.37%)  3
Nausea  1  34/120 (28.33%)  42 5/89 (5.62%)  6
Vomiting  1  16/120 (13.33%)  24 8/89 (8.99%)  9
General disorders     
Fatigue  1  31/120 (25.83%)  34 9/89 (10.11%)  11
Irritability  1  14/120 (11.67%)  15 8/89 (8.99%)  11
Pyrexia  1  2/120 (1.67%)  3 6/89 (6.74%)  6
Therapeutic response unexpected  1  6/120 (5.00%)  12 2/89 (2.25%)  2
Investigations     
Weight decreased  1  6/120 (5.00%)  6 1/89 (1.12%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  22/120 (18.33%)  22 4/89 (4.49%)  5
Nervous system disorders     
Dizziness  1  15/120 (12.50%)  16 5/89 (5.62%)  5
Headache  1  27/120 (22.50%)  36 16/89 (17.98%)  21
Somnolence  1  10/120 (8.33%)  12 0/89 (0.00%)  0
Psychiatric disorders     
Aggression  1  6/120 (5.00%)  6 0/89 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/120 (5.00%)  6 8/89 (8.99%)  8
Oropharyngeal pain  1  6/120 (5.00%)  6 6/89 (6.74%)  6
Skin and subcutaneous tissue disorders     
Rash  1  6/120 (5.00%)  6 6/89 (6.74%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00607919     History of Changes
Other Study ID Numbers: 11672
B4Z-US-LYEB ( Other Identifier: Eli Lilly and Company )
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: November 11, 2011
Results First Posted: December 15, 2011
Last Update Posted: December 15, 2011