Trial Outcomes & Findings for Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder (NCT NCT00380692)
NCT ID: NCT00380692
Last Updated: 2010-05-11
Results Overview
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
Baseline and 8 weeks
Results posted on
2010-05-11
Participant Flow
Study Period I was a screening and wash-out period. Study Period II (visits 2-6) was an 8-week double-blind period. Patients were randomized at Visit 2. Study Period III (visits 6-11) was a 20-week open-label extension period. Treatment groups in Study Period III refer to treatment group assignment during Double-Blind Period.
Participant milestones
| Measure |
Atomoxetine
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Study Period II - Double Blind
STARTED
|
48
|
49
|
|
Study Period II - Double Blind
COMPLETED
|
43
|
46
|
|
Study Period II - Double Blind
NOT COMPLETED
|
5
|
3
|
|
Study Period III - Open Label
STARTED
|
42
|
46
|
|
Study Period III - Open Label
COMPLETED
|
36
|
34
|
|
Study Period III - Open Label
NOT COMPLETED
|
6
|
12
|
Reasons for withdrawal
| Measure |
Atomoxetine
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Study Period II - Double Blind
Adverse Event
|
1
|
0
|
|
Study Period II - Double Blind
Protocol Violation
|
2
|
2
|
|
Study Period II - Double Blind
Withdrawal by Subject
|
0
|
0
|
|
Study Period II - Double Blind
Physician Decision
|
0
|
1
|
|
Study Period II - Double Blind
Lack of Efficacy
|
1
|
0
|
|
Study Period II - Double Blind
Parent/Caregiver Decision
|
1
|
0
|
|
Study Period III - Open Label
Adverse Event
|
5
|
3
|
|
Study Period III - Open Label
Protocol Violation
|
0
|
0
|
|
Study Period III - Open Label
Withdrawal by Subject
|
0
|
1
|
|
Study Period III - Open Label
Physician Decision
|
0
|
3
|
|
Study Period III - Open Label
Lack of Efficacy
|
0
|
4
|
|
Study Period III - Open Label
Parent/Caregiver Decision
|
1
|
1
|
Baseline Characteristics
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
9.9 years
STANDARD_DEVIATION 2.72 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 2.90 • n=7 Participants
|
9.9 years
STANDARD_DEVIATION 2.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Race/Ethnicity
Caucasian
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Race/Ethnicity
African
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version- Total Score
|
40.7 units on a scale
STANDARD_DEVIATION 7.47 • n=5 Participants
|
38.6 units on a scale
STANDARD_DEVIATION 8.43 • n=7 Participants
|
39.6 units on a scale
STANDARD_DEVIATION 8.00 • n=5 Participants
|
|
Autism Diagnostic Interview-Revised (ADI-R)
|
37.4 units on a scale
STANDARD_DEVIATION 12.45 • n=5 Participants
|
37.2 units on a scale
STANDARD_DEVIATION 9.68 • n=7 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 11.09 • n=5 Participants
|
|
Body Mass Index
|
18.5 kilogram/meter squared
STANDARD_DEVIATION 3.40 • n=5 Participants
|
18.1 kilogram/meter squared
STANDARD_DEVIATION 3.36 • n=7 Participants
|
18.3 kilogram/meter squared
STANDARD_DEVIATION 3.37 • n=5 Participants
|
|
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale
|
5.0 units on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.90 • n=7 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.83 • n=5 Participants
|
|
Height
|
146.0 centimeters
STANDARD_DEVIATION 16.57 • n=5 Participants
|
148.0 centimeters
STANDARD_DEVIATION 19.11 • n=7 Participants
|
147.0 centimeters
STANDARD_DEVIATION 17.84 • n=5 Participants
|
|
Score for Performance IQ
|
89.9 units on a scale
STANDARD_DEVIATION 16.59 • n=5 Participants
|
94.9 units on a scale
STANDARD_DEVIATION 17.46 • n=7 Participants
|
92.4 units on a scale
STANDARD_DEVIATION 17.14 • n=5 Participants
|
|
Score for Verbal IQ
|
93.2 units on a scale
STANDARD_DEVIATION 18.49 • n=5 Participants
|
94.4 units on a scale
STANDARD_DEVIATION 18.26 • n=7 Participants
|
93.8 units on a scale
STANDARD_DEVIATION 18.29 • n=5 Participants
|
|
Score for the Overall Scale Intelligence
|
91.0 units on a scale
STANDARD_DEVIATION 16.41 • n=5 Participants
|
94.6 units on a scale
STANDARD_DEVIATION 17.71 • n=7 Participants
|
92.9 units on a scale
STANDARD_DEVIATION 17.08 • n=5 Participants
|
|
Weight
|
41.0 kilograms
STANDARD_DEVIATION 14.92 • n=5 Participants
|
41.5 kilograms
STANDARD_DEVIATION 16.12 • n=7 Participants
|
41.2 kilograms
STANDARD_DEVIATION 15.46 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksPopulation: Number of randomized participants with a value at baseline and 8 week endpoint. Last Observation Carried Forward analysis.
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders, Version IV (DSM-IV) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
Baseline Total Score (n=48, n=49)
|
40.7 units on a scale
Standard Deviation 7.47
|
38.6 units on a scale
Standard Deviation 8.43
|
|
ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score
8 Week Endpoint Total Score (n=43, n=47)
|
32.3 units on a scale
Standard Deviation 10.97
|
37.3 units on a scale
Standard Deviation 9.57
|
SECONDARY outcome
Timeframe: 8 weeks, 28 weeksPopulation: Number of randomized participants with values at timepoint.
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).
Outcome measures
| Measure |
Atomoxetine
n=43 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=46 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)
8 Week Improvement Score
|
3.5 units on a scale
Standard Deviation 1.08
|
3.9 units on a scale
Standard Deviation 0.96
|
|
Clinical Global Impressions-ADHD-Improvement (CGI-ADHD - I)
28 Week Improvement Score (n=39, n=35)
|
2.5 units on a scale
Standard Deviation 1.14
|
2.7 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 28 weeksPopulation: Number of randomized participants who had a value at timepoint.
A 28-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.
Outcome measures
| Measure |
Atomoxetine
n=42 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=44 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
ADHD: Baseline (n=42, n=44)
|
18.5 units on a scale
Standard Deviation 9.27
|
18.1 units on a scale
Standard Deviation 7.49
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
ADHD: 8 Week (n=36, n=36)
|
15.8 units on a scale
Standard Deviation 9.85
|
17.2 units on a scale
Standard Deviation 8.69
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Hyperactivity: Baseline (n=42, n=44)
|
8.8 units on a scale
Standard Deviation 5.50
|
8.2 units on a scale
Standard Deviation 5.06
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Hyperactivity: 8 Week (n=36, n=36)
|
7.6 units on a scale
Standard Deviation 5.54
|
8.3 units on a scale
Standard Deviation 5.63
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Hyperactivity: 28 Week (n=26, n=25)
|
6.0 units on a scale
Standard Deviation 4.90
|
5.2 units on a scale
Standard Deviation 4.13
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Cognitive/Attention: Baseline (n=40, n=44)
|
6.8 units on a scale
Standard Deviation 4.45
|
4.8 units on a scale
Standard Deviation 3.68
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Cognitive/Attention: 8 Week (n=34, n=36)
|
6.1 units on a scale
Standard Deviation 4.56
|
4.6 units on a scale
Standard Deviation 3.53
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Cognitive/Attention: 28 Week (n=26, n=25)
|
4.7 units on a scale
Standard Deviation 3.58
|
4.6 units on a scale
Standard Deviation 3.85
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Oppositional: Baseline (n=42, n=44)
|
4.1 units on a scale
Standard Deviation 3.54
|
3.6 units on a scale
Standard Deviation 3.53
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Oppositional: 8 Week (n=36, n=36)
|
3.8 units on a scale
Standard Deviation 4.43
|
3.4 units on a scale
Standard Deviation 3.35
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
Oppositional: 28 Week (n=26, n= 25)
|
2.3 units on a scale
Standard Deviation 3.33
|
1.4 units on a scale
Standard Deviation 1.98
|
|
Conners' Teacher Rating Scale - Revised: Short Form (CTRS-R:S)
ADHD: 28 Week (n=26, n=25)
|
13.5 units on a scale
Standard Deviation 8.61
|
12.5 units on a scale
Standard Deviation 5.95
|
SECONDARY outcome
Timeframe: 28 weeksPopulation: Randomized participants with a value at timepoint.
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Outcome measures
| Measure |
Atomoxetine
n=38 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=35 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
ADHD Rating Scale-IV-Parent Version: Investigator Scored Total Score
|
23.6 units on a scale
Standard Deviation 11.81
|
25.9 units on a scale
Standard Deviation 10.58
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 28 weeksPopulation: Randomized participants with a value at timepoint.
10-item parent-based scale assessing sleep problems (6 point Likert scale). Scores: Difficulty falling asleep (1-6); Quality of sleep (3-18); Functional outcome (6-36). Lower scores indicate higher problems with item. Open-ended items: Time to fall asleep (1 \[0-15 minutes\] to 5 \[\>1 hour\]); Total hours (numbers associated with hours of sleep).
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Sleep Measure Scale
Quality of Sleep: 8 Week (n=43, n=46)
|
14.2 units on a scale
Standard Deviation 3.08
|
14.9 units on a scale
Standard Deviation 2.86
|
|
Sleep Measure Scale
Quality of Sleep: 28 Week (n=38, n=36)
|
14.6 units on a scale
Standard Deviation 2.88
|
15.0 units on a scale
Standard Deviation 2.35
|
|
Sleep Measure Scale
Functional Outcome During Day:Baseline (n=48,n=49)
|
29.6 units on a scale
Standard Deviation 4.69
|
30.0 units on a scale
Standard Deviation 4.07
|
|
Sleep Measure Scale
Functional Outcome During Day:8 Week (n=43,n=46)
|
29.1 units on a scale
Standard Deviation 5.09
|
30.0 units on a scale
Standard Deviation 4.80
|
|
Sleep Measure Scale
Functional Outcome During Day:28Week (n=38,n=36)
|
27.8 units on a scale
Standard Deviation 6.38
|
29.6 units on a scale
Standard Deviation 4.76
|
|
Sleep Measure Scale
Time to Fall Asleep: Baseline (n=48, n=49)
|
2.9 units on a scale
Standard Deviation 1.49
|
2.8 units on a scale
Standard Deviation 1.41
|
|
Sleep Measure Scale
Time to Fall Asleep: 8 Week (n=43, n=46)
|
2.6 units on a scale
Standard Deviation 1.43
|
3.0 units on a scale
Standard Deviation 1.34
|
|
Sleep Measure Scale
Time to Fall Asleep: 28 Week (n=35, n=35)
|
3.1 units on a scale
Standard Deviation 1.49
|
2.6 units on a scale
Standard Deviation 1.14
|
|
Sleep Measure Scale
Difficulty Falling Asleep: Baseline (n=48, n=49)
|
3.4 units on a scale
Standard Deviation 1.91
|
3.3 units on a scale
Standard Deviation 1.58
|
|
Sleep Measure Scale
Difficulty Falling Asleep: 8 Week (n=43, n=46)
|
3.6 units on a scale
Standard Deviation 1.80
|
3.3 units on a scale
Standard Deviation 1.64
|
|
Sleep Measure Scale
Difficulty Falling Asleep: 28 Week (n=38, n=36)
|
3.2 units on a scale
Standard Deviation 1.76
|
3.7 units on a scale
Standard Deviation 1.69
|
|
Sleep Measure Scale
Total Hours of Sleep: Baseline (n=48, n=49)
|
9.1 units on a scale
Standard Deviation 1.38
|
9.3 units on a scale
Standard Deviation 1.46
|
|
Sleep Measure Scale
Total Hours of Sleep: 8 Weeks (n=42, n=46)
|
8.9 units on a scale
Standard Deviation 1.49
|
9.1 units on a scale
Standard Deviation 1.51
|
|
Sleep Measure Scale
Total Hours of Sleep: 28 Week (n=36, n=34)
|
8.9 units on a scale
Standard Deviation 1.61
|
9.2 units on a scale
Standard Deviation 1.12
|
|
Sleep Measure Scale
Quality of Sleep: Baseline (n=48, n=49)
|
14.1 units on a scale
Standard Deviation 2.85
|
14.4 units on a scale
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 28 weeksPopulation: Randomized participants with values at timepoint.
The ABC is a 58-item informant-based scale comprised of five subscales (Irritability \[15 items\], Lethargy \[16\], Stereotypic Behaviors \[7\], Hyperactivity \[16\], Inappropriate Speech \[4\]). Individual item scores range from 0 (no problem) to 3 (severe problem). Subscale scores are total of individual item scores in subscale: Irritability (0-45); Lethargy (0-48); Stereotypic (0-21); Hyperactivity (0-48); Inappropriate Speech (0-12).
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Aberrant Behavior Checklist (ABC)
Inappropriate Speech: 28 Week (n=38, n=36)
|
3.1 units on a scale
Standard Deviation 3.22
|
2.9 units on a scale
Standard Deviation 2.35
|
|
Aberrant Behavior Checklist (ABC)
Lethargy: 28 Week (n=38 , n=36)
|
7.5 units on a scale
Standard Deviation 7.24
|
8.4 units on a scale
Standard Deviation 6.64
|
|
Aberrant Behavior Checklist (ABC)
Stereotypic: Baseline (n=47, n=49)
|
6.6 units on a scale
Standard Deviation 5.07
|
4.1 units on a scale
Standard Deviation 4.47
|
|
Aberrant Behavior Checklist (ABC)
Stereotypic: 8 Week (n=43, n=46)
|
3.6 units on a scale
Standard Deviation 4.01
|
3.6 units on a scale
Standard Deviation 4.12
|
|
Aberrant Behavior Checklist (ABC)
Stereotypic: 28 Week (n=38, n=36)
|
3.3 units on a scale
Standard Deviation 4.03
|
1.7 units on a scale
Standard Deviation 2.77
|
|
Aberrant Behavior Checklist (ABC)
Irritiability: Baseline (n=47, n=49)
|
17.4 units on a scale
Standard Deviation 9.15
|
16.2 units on a scale
Standard Deviation 9.49
|
|
Aberrant Behavior Checklist (ABC)
Irritiability: 8 Week (n=43, n=46)
|
14.5 units on a scale
Standard Deviation 9.36
|
15.4 units on a scale
Standard Deviation 9.80
|
|
Aberrant Behavior Checklist (ABC)
Irritiability: 28 Week (n=38, n=36)
|
11.5 units on a scale
Standard Deviation 10.12
|
10.4 units on a scale
Standard Deviation 8.05
|
|
Aberrant Behavior Checklist (ABC)
Lethargy: Baseline (n=47, n=49)
|
12.7 units on a scale
Standard Deviation 8.33
|
12.5 units on a scale
Standard Deviation 8.03
|
|
Aberrant Behavior Checklist (ABC)
Lethargy: 8 Week (n=43, n=46)
|
11.1 units on a scale
Standard Deviation 9.34
|
11.5 units on a scale
Standard Deviation 8.17
|
|
Aberrant Behavior Checklist (ABC)
Hyperactivity: Baseline (n=47, n=49)
|
28.2 units on a scale
Standard Deviation 9.40
|
25.5 units on a scale
Standard Deviation 11.56
|
|
Aberrant Behavior Checklist (ABC)
Hyperactivity: 8 Week (n=43, n=45)
|
22.5 units on a scale
Standard Deviation 11.05
|
24.6 units on a scale
Standard Deviation 10.33
|
|
Aberrant Behavior Checklist (ABC)
Hyperactivity: 28 Week (n=38, n=36)
|
16.4 units on a scale
Standard Deviation 12.17
|
16.0 units on a scale
Standard Deviation 9.60
|
|
Aberrant Behavior Checklist (ABC)
Inappropriate Speech: Baseline (n=47, n=49)
|
4.8 units on a scale
Standard Deviation 3.21
|
4.6 units on a scale
Standard Deviation 3.35
|
|
Aberrant Behavior Checklist (ABC)
Inappropriate Speech: 8 Week (n=43, n=46)
|
3.8 units on a scale
Standard Deviation 2.92
|
4.5 units on a scale
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 28 weeksPopulation: Randomized participants with value at timepoint.
CSBQ is filled out by parents and consists of 49 items. Items are rated in an ordinal rather than a discrete fashion in order to establish the extent to which problems are present. The CSBQ consists of six subscales. Individual item scores range from 0=does not apply to 2=applies clearly. Total score ranges from 0 to 98.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Children's Social Behavior Questionnaire (CSBQ) Total Score
8 Week (n=43, n=46)
|
46.1 units on a scale
Standard Deviation 15.88
|
50.2 units on a scale
Standard Deviation 14.62
|
|
Children's Social Behavior Questionnaire (CSBQ) Total Score
Baseline (n=48, n=49)
|
53.6 units on a scale
Standard Deviation 14.81
|
52.4 units on a scale
Standard Deviation 15.97
|
|
Children's Social Behavior Questionnaire (CSBQ) Total Score
28 Week (n=38, n=35)
|
40.4 units on a scale
Standard Deviation 19.55
|
43.6 units on a scale
Standard Deviation 17.26
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 28 weeksPopulation: Randomized participants with value at timepoint.
Parental distress is measured with the GHQ. The raw total score (based on 0-0-1-1 scoring system) can be used as an overall index of psychological distress, ranging from 0 to 12 with higher scores indicating more distress.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
General Health Questionnaire (GHQ) Total Score
Baseline (n=48, n=49)
|
2.9 units on a scale
Standard Deviation 3.45
|
4.0 units on a scale
Standard Deviation 3.79
|
|
General Health Questionnaire (GHQ) Total Score
8 Week (n=43, n=46)
|
2.3 units on a scale
Standard Deviation 3.35
|
3.1 units on a scale
Standard Deviation 3.31
|
|
General Health Questionnaire (GHQ) Total Score
28 Week (n=38, n=36)
|
1.7 units on a scale
Standard Deviation 2.61
|
2.3 units on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, 28 weeksPopulation: Randomized participants with value at timepoint.
The NOSI contains 123 items to be completed by the primary caregiver. Individual item scores range from 1 (completely agree) to 6 (completely disagree). Total scores range from 123 to 738.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Nijmeegse Ouderlijke Stress Index (NOSI) Total Score
Baseline (n=42, n=44)
|
368.6 units on a scale
Standard Deviation 79.22
|
379.5 units on a scale
Standard Deviation 78.74
|
|
Nijmeegse Ouderlijke Stress Index (NOSI) Total Score
8 Week (n=38, n=39)
|
350.0 units on a scale
Standard Deviation 75.07
|
368.8 units on a scale
Standard Deviation 81.83
|
|
Nijmeegse Ouderlijke Stress Index (NOSI) Total Score
28 Week (n=35, n=34)
|
325.2 units on a scale
Standard Deviation 85.76
|
328.4 units on a scale
Standard Deviation 89.23
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
Focused attention assessed distractibility. Child needs to identify a specific target (eg, Cherry); non-target is any other fruit. Child presses "yes" when target occurs in relevant position (eg, one of vertical positions on diamond). Child presses "no" when target is absent, or when target appears on horizontal position (irrelevant target). Error rates are percentage of missing relevant targets and percentage of false alarms in response to (irr)relevant (non)targets based on number of errors/total number of trials X 100.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
Irrelevant Targets Baseline (n=35, n=44)
|
12.3 error rate (percentage)
Standard Deviation 13.95
|
11.8 error rate (percentage)
Standard Deviation 16.06
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
Irrelevant Targets 8 Week (n=35, n=44)
|
10.0 error rate (percentage)
Standard Deviation 16.09
|
13.3 error rate (percentage)
Standard Deviation 14.36
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
Relevant Nontargets Baseline (n=35, n=44)
|
5.7 error rate (percentage)
Standard Deviation 8.15
|
2.9 error rate (percentage)
Standard Deviation 5.97
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
Relevant Targets Baseline (n=35, n=44)
|
4.8 error rate (percentage)
Standard Deviation 5.49
|
6.9 error rate (percentage)
Standard Deviation 9.04
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
Relevant Nontargets 8 Week (n=35, n=44)
|
5.1 error rate (percentage)
Standard Deviation 9.48
|
3.3 error rate (percentage)
Standard Deviation 7.04
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Error Rates
Relevant Targets 8 Week (n=35, n=44)
|
7.3 error rate (percentage)
Standard Deviation 9.42
|
7.2 error rate (percentage)
Standard Deviation 14.47
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
Task is the same as described in Outcome Measure #10. Reaction times (RT) for hits are mean RTs of correct responses to relevant targets. RTs for correct rejections are mean RTs for correct rejections are mean RTs for correct no responses to irrelevant targets and relevant nontargets.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
Mean Reaction Time Hits Baseline (n=34, n=42)
|
1045.6 milliseconds
Standard Deviation 411.14
|
1084.4 milliseconds
Standard Deviation 518.50
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
Mean Reaction Time Hits 8 Week (n=33, n=43)
|
1013.0 milliseconds
Standard Deviation 505.52
|
1017.7 milliseconds
Standard Deviation 475.82
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
Irrelevant Target Baseline (n=34, n=42)
|
1260.1 milliseconds
Standard Deviation 413.09
|
1217.3 milliseconds
Standard Deviation 533.92
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
Irrelevant Target 8 Week (n=32, n=43)
|
1167.8 milliseconds
Standard Deviation 493.57
|
1206.0 milliseconds
Standard Deviation 547.64
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
Relevant Nontarget Baseline (n=34, n=43)
|
1208.4 milliseconds
Standard Deviation 509.62
|
1220.9 milliseconds
Standard Deviation 550.25
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Reaction Times for Hits and Correct Rejections
Relevant Nontarget 8 Week (n=33, n=43)
|
1165.4 milliseconds
Standard Deviation 570.35
|
1168.9 milliseconds
Standard Deviation 569.16
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
Task is the same as described in Outcome Measure #10. Standard deviations of reaction times (RT) assess intraindividual variability in RT and refer to the same conditions as those for mean reaction times described in Outcome Measure #11.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
Irrelevant Target 8 Week (n=29, n=41)
|
341.0 milliseconds
Standard Deviation 259.84
|
431.7 milliseconds
Standard Deviation 363.62
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
Standard Deviation Hits Baseline (n=33, n=39)
|
434.3 milliseconds
Standard Deviation 302.61
|
497.9 milliseconds
Standard Deviation 365.48
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
Relevant Nontarget Baseline (n=33, n=40)
|
442.2 milliseconds
Standard Deviation 374.99
|
565.6 milliseconds
Standard Deviation 455.54
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
Relevant Nontarget 8 Week (n=30, n=41)
|
442.6 milliseconds
Standard Deviation 413.74
|
455.6 milliseconds
Standard Deviation 376.87
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
Standard Deviation Hits 8 Week (n=30, n=41)
|
381.5 milliseconds
Standard Deviation 286.96
|
393.9 milliseconds
Standard Deviation 299.08
|
|
Amsterdam Neuropsychological Tasks (ANT): Focused Attention Task - Standard Deviation of Reaction Times for Hits and Correct Rejections
Irrelevant Target Baseline (n=33, n=39)
|
421.0 milliseconds
Standard Deviation 263.84
|
429.4 milliseconds
Standard Deviation 382.61
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
The memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to identify (e.g., an animal). A "yes" is required whenever the target is part of the displayed set of four stimuli (all animals). Load 2 has 2 targets. Whenever 1 of the targets appears in the successively displayed sets of four animals, a "yes" is required. Targets are present in 50% of trials. Error rates are the percentages of errors made in each task condition, based on the number of errors/total number of trials X 100.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Absent Targets Load 1 8 Week (n=34, n=35)
|
5.3 error rate (percentage)
Standard Deviation 6.96
|
7.6 error rate (percentage)
Standard Deviation 13.25
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Present Targets Load 1 Baseline (n=34, n=35)
|
6.5 error rate (percentage)
Standard Deviation 9.66
|
6.6 error rate (percentage)
Standard Deviation 6.84
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Absent Targets Load 2 Baseline (n=33, n=35)
|
2.0 error rate (percentage)
Standard Deviation 3.52
|
4.4 error rate (percentage)
Standard Deviation 9.61
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Absent Targets Load 2 8 Week (n=34, n=35)
|
4.0 error rate (percentage)
Standard Deviation 6.83
|
4.3 error rate (percentage)
Standard Deviation 6.20
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Absent Targets Load 1 Baseline (n=34, n=35)
|
5.9 error rate (percentage)
Standard Deviation 14.06
|
5.1 error rate (percentage)
Standard Deviation 5.49
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Present Targets Load 1 8 Week (34, n=35)
|
7.6 error rate (percentage)
Standard Deviation 9.07
|
7.9 error rate (percentage)
Standard Deviation 10.93
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Present Targets Load 2 Baseline (n=33, n=35)
|
9.5 error rate (percentage)
Standard Deviation 9.38
|
9.7 error rate (percentage)
Standard Deviation 10.07
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Error Rates
Present Targets Load 2 8 Week (n=34, n=35)
|
8.7 error rate (percentage)
Standard Deviation 10.10
|
10.1 error rate (percentage)
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
Memory search task aims at measuring serial search processes to be carried out in working memory. There are 2 blocks (loads) with 40 trials each. Load 1 has 1 target to remember (one animal). A "yes" is required whenever the target is part of displayed set of 4 animals. Load 2 has 2 animals. A "yes" is required whenever one of the animals appears in successively displayed sets of 4 animals. Targets are present in 50% of the trials. Reaction time (RT) for hits is mean RT of correct "yes" responses to targets. RT correct rejections are mean RTs of correct "no" responses when target was missing.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Load 2 8 Week (n=34, n=34)
|
1130.4 milliseconds
Standard Deviation 460.66
|
1294.2 milliseconds
Standard Deviation 552.25
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Load 1 Baseline (n=33, n=35)
|
1051.9 milliseconds
Standard Deviation 338.41
|
1010.4 milliseconds
Standard Deviation 382.92
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Load 1 8 Week (n=34, n=34)
|
1014.8 milliseconds
Standard Deviation 394.58
|
928.7 milliseconds
Standard Deviation 301.04
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Load 2 Baseline (n=32, n=34)
|
1411.0 milliseconds
Standard Deviation 357.50
|
1387.2 milliseconds
Standard Deviation 595.37
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Reaction Time Hits Load 1 Baseline (n=33, n=35)
|
932.7 milliseconds
Standard Deviation 295.14
|
881.7 milliseconds
Standard Deviation 304.42
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Reaction Time Hits Load 1 8 Week (n=34, n=34)
|
882.4 milliseconds
Standard Deviation 327.30
|
786.8 milliseconds
Standard Deviation 257.19
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Reaction Time Hits Load 2 Baseline (n=32, n=34)
|
1131.5 milliseconds
Standard Deviation 293.84
|
1111.8 milliseconds
Standard Deviation 442.97
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Reaction Times for Hits and Correct Rejections
Reaction Time Hits Load 2 8 Week (n=34, n=34)
|
1060.0 milliseconds
Standard Deviation 343.53
|
1110.8 milliseconds
Standard Deviation 445.61
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
Task is the same as described in Outcome Measure #14. Standard deviations of reaction times (RT) assess intraindividual variability in RT referring to the two conditions creating hits and correct rejections as mentioned in Outcome Measure #14.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
SD Hits Load 2 Baseline (n=31, n=34)
|
416.8 milliseconds
Standard Deviation 226.87
|
424.6 milliseconds
Standard Deviation 301.20
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
SD Hits Load 2 8 Week (n=32, n=33)
|
380.6 milliseconds
Standard Deviation 280.36
|
501.0 milliseconds
Standard Deviation 382.32
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
Load 1 Baseline (n=32, n=35)
|
406.2 milliseconds
Standard Deviation 280.59
|
415.0 milliseconds
Standard Deviation 324.66
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
Load 1 8 Week (n=32, n=33)
|
408.2 milliseconds
Standard Deviation 342.39
|
353.2 milliseconds
Standard Deviation 273.16
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
Load 2 Baseline (n=31, n=34)
|
515.4 milliseconds
Standard Deviation 275.40
|
577.4 milliseconds
Standard Deviation 340.89
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
Load 2 8 Week (n=32, n=33)
|
544.9 milliseconds
Standard Deviation 338.26
|
580.5 milliseconds
Standard Deviation 375.88
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
SD Hits Load 1 Baseline (n=32, n=34)
|
308.7 milliseconds
Standard Deviation 239.10
|
320.3 milliseconds
Standard Deviation 263.73
|
|
Amsterdam Neuropsychological Tasks (ANT): Memory Search Task - Standard Deviation (SD) of Reaction Times for Hits and Correct Rejections
SD Hits Load 1 8 Week (n=33, n=33)
|
261.6 milliseconds
Standard Deviation 231.32
|
232.5 milliseconds
Standard Deviation 165.44
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Number of participants with baseline and non-missing postbaseline value at visit.
A complex visuo-motor flexibility task that aims at measuring eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Accuracy is the mean distance between the mouse cursor and the moving target.
Outcome measures
| Measure |
Atomoxetine
n=31 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=33 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy
Baseline (n=30,n=33)
|
7.8 millimeters
Standard Deviation 5.62
|
8.1 millimeters
Standard Deviation 5.49
|
|
Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Accuracy
8 Week (n=31,n=33)
|
8.2 millimeters
Standard Deviation 6.88
|
10.1 millimeters
Standard Deviation 11.92
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Number of participants with baseline and non-missing postbaseline value at visit.
A complex visuo-motor flexibility task that measures eye-hand co-ordination and fine motor control. By moving mouse cursor, the child is required to follow as closely as possible a target that randomly moves across the PC-screen. Stability is within subject variability of mean distance between cursor and target.
Outcome measures
| Measure |
Atomoxetine
n=31 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=33 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement
Baseline (n=30,n=33)
|
7.6 millimeters
Standard Deviation 8.24
|
8.2 millimeters
Standard Deviation 7.90
|
|
Amsterdam Neuropsychological Tasks (ANT): Pursuit Motor Control Task - Stability of Movement
8 Week (n=31,n=33)
|
8.2 millimeters
Standard Deviation 8.61
|
9.4 millimeters
Standard Deviation 9.24
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Number of participants with baseline and a non-missing postbaseline value at visit.
Measures inhibition of pre-potent responses. 24 Go signals (open squares) are presented, randomly mixed with 24 No-Go signals (closed squares). Subjects are required to press a key if a Go signal (target) appears on the screen but to withhold a response if they see a No-Go signal. Error rate is the percentage of key presses to No-Go signals/total number of trials X 100.
Outcome measures
| Measure |
Atomoxetine
n=37 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=45 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates
Absent Target Baseline
|
8.0 error rate (percentage)
Standard Deviation 16.30
|
6.8 error rate (percentage)
Standard Deviation 8.49
|
|
Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates
Absent Target 8 Week
|
4.5 error rate (percentage)
Standard Deviation 4.75
|
9.0 error rate (percentage)
Standard Deviation 15.07
|
|
Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates
Present Target Baseline
|
2.0 error rate (percentage)
Standard Deviation 5.25
|
2.9 error rate (percentage)
Standard Deviation 6.14
|
|
Amsterdam Neuropsychological Tasks (ANT): Go/No-Go Response Inhibition Task - Error Rates
Present Target 8 Week
|
3.7 error rate (percentage)
Standard Deviation 10.01
|
1.9 error rate (percentage)
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Number of participants with baseline and one non-missing postbaseline value at visit.
Measures ability to neglect stimuli interfering with predefined stimulus-response coupling. Child presented with displays of 9 colored squares. Child responds to color of central square by pressing left mouse key when blue, and right mouse key when yellow. Part 1 (40 trials), surrounding squares may be same color (compatible) or different (neutral). Part 2 (80 trials), in 50% of trials, surrounding squares have color corresponding to predefined key press for other hand (incompatible). Error rates are percentages of errors in response to compatible and incompatible signals, respectively.
Outcome measures
| Measure |
Atomoxetine
n=33 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=35 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates
Compatible Signals Baseline (n=32, n=35)
|
7.7 error rate (percentages)
Standard Deviation 9.80
|
8.5 error rate (percentages)
Standard Deviation 10.06
|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates
Compatible Signals 8 Week (n=33, n=35)
|
-2.1 error rate (percentages)
Standard Deviation 8.92
|
-1.8 error rate (percentages)
Standard Deviation 11.43
|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates
Incompatible Signals Baseline (n=32, n=35)
|
8.4 error rate (percentages)
Standard Deviation 10.33
|
9.1 error rate (percentages)
Standard Deviation 6.62
|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Error Rates
Incompatible Signals 8 Week (n=32, n=35)
|
-0.4 error rate (percentages)
Standard Deviation 11.11
|
0.1 error rate (percentages)
Standard Deviation 8.19
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: Number of participants with baseline and non-missing postbaseline value at visit.
Task is the same as described in Outcome Measure #19. Mean reaction times (RTs) are computed for correct responses to compatible and incompatible flankers, respectively.
Outcome measures
| Measure |
Atomoxetine
n=33 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=35 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times
Compatible Flankers Part 2 Baseline (n=31,n=34)
|
863.1 milliseconds
Standard Deviation 234.70
|
925.4 milliseconds
Standard Deviation 384.55
|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times
Compatible Flankers Part 2 8 Week (n=33,n=35)
|
901.1 milliseconds
Standard Deviation 350.27
|
897.7 milliseconds
Standard Deviation 376.63
|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times
Incompatible Flankers Part 2 Baseline (n=31,n=35)
|
959.4 milliseconds
Standard Deviation 295.32
|
976.5 milliseconds
Standard Deviation 412.76
|
|
Amsterdam Neuropsychological Tasks (ANT): Flanker Interference Task - Reaction Times
Incompatible Flankers Part 2 8 Week (n=33,n=35)
|
931.9 milliseconds
Standard Deviation 347.99
|
946.2 milliseconds
Standard Deviation 419.63
|
SECONDARY outcome
Timeframe: baselinePopulation: All randomized participants.
Genotype characterization was used to determine participants' metabolic status.
Outcome measures
| Measure |
Atomoxetine
n=48 Participants
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 Participants
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Cytochrome P450 2D6 Genotype
Missing
|
1 participants
|
0 participants
|
|
Cytochrome P450 2D6 Genotype
Extensive Metabolizer
|
28 participants
|
28 participants
|
|
Cytochrome P450 2D6 Genotype
Intermediate Metabolizer
|
13 participants
|
15 participants
|
|
Cytochrome P450 2D6 Genotype
Poor Metabolizer
|
6 participants
|
6 participants
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=48 participants at risk
atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
|
Placebo
n=49 participants at risk
placebo: daily (QD), by mouth (PO) for 8 weeks.
Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
4/48 • Number of events 5
|
6.1%
3/49 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
18.8%
9/48 • Number of events 9
|
6.1%
3/49 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/48 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
29.2%
14/48 • Number of events 15
|
8.2%
4/49 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
14.6%
7/48 • Number of events 10
|
10.2%
5/49 • Number of events 6
|
|
General disorders
Fatigue
|
22.9%
11/48 • Number of events 12
|
8.2%
4/49 • Number of events 4
|
|
General disorders
Pyrexia
|
0.00%
0/48
|
6.1%
3/49 • Number of events 3
|
|
Infections and infestations
Influenza
|
6.2%
3/48 • Number of events 3
|
0.00%
0/49
|
|
Metabolism and nutrition disorders
Decreased appetite
|
27.1%
13/48 • Number of events 13
|
6.1%
3/49 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
3/48 • Number of events 3
|
0.00%
0/49
|
|
Nervous system disorders
Dizziness
|
6.2%
3/48 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Headache
|
25.0%
12/48 • Number of events 17
|
18.4%
9/49 • Number of events 13
|
|
Nervous system disorders
Psychomotor hyperactivity
|
2.1%
1/48 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
|
Psychiatric disorders
Aggression
|
4.2%
2/48 • Number of events 2
|
6.1%
3/49 • Number of events 3
|
|
Psychiatric disorders
Early morning awakening
|
10.4%
5/48 • Number of events 5
|
0.00%
0/49
|
|
Psychiatric disorders
Initial insomnia
|
6.2%
3/48 • Number of events 3
|
10.2%
5/49 • Number of events 5
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60