Trial Outcomes & Findings for Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00320528)
NCT ID: NCT00320528
Last Updated: 2010-01-06
Results Overview
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
269 participants
Primary outcome timeframe
Baseline, 12 Weeks
Results posted on
2010-01-06
Participant Flow
Study Period I was a 3-day screening period. Study Period II was 12 weeks long. Study Period III was an optional additional 12 week open-label extension. Results are presented for Period II (patients who received at least one dose of study drug).
Participant milestones
| Measure |
Pure ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Study Period II
STARTED
|
98
|
41
|
130
|
|
Study Period II
Received at Least One Dose of Study Drug
|
97
|
38
|
128
|
|
Study Period II
COMPLETED
|
87
|
31
|
108
|
|
Study Period II
NOT COMPLETED
|
11
|
10
|
22
|
|
Study Period III
STARTED
|
87
|
31
|
108
|
|
Study Period III
COMPLETED
|
0
|
0
|
2
|
|
Study Period III
NOT COMPLETED
|
87
|
31
|
106
|
Reasons for withdrawal
| Measure |
Pure ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Study Period II
Adverse Event
|
3
|
4
|
8
|
|
Study Period II
Parent/Caregiver Decision
|
8
|
3
|
11
|
|
Study Period II
Withdrawal by Subject
|
0
|
1
|
1
|
|
Study Period II
Entry Criteria Exclusion
|
0
|
2
|
2
|
|
Study Period III
Adverse Event
|
1
|
0
|
0
|
|
Study Period III
Lost to Follow-up
|
1
|
0
|
0
|
|
Study Period III
Withdrawal by Subject
|
1
|
1
|
2
|
|
Study Period III
Lack of Efficacy
|
2
|
0
|
0
|
|
Study Period III
Parent/Caregiver Decision
|
14
|
3
|
11
|
|
Study Period III
Protocol Violation
|
0
|
1
|
0
|
|
Study Period III
Physician Decision
|
0
|
1
|
2
|
|
Study Period III
Sponsor Decision
|
0
|
0
|
1
|
|
Study Period III
Atomoxetine Commercially Available
|
68
|
25
|
90
|
Baseline Characteristics
Efficacy of Atomoxetine on Psychosocial Function of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Pure ADHD
n=97 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=38 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=128 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
10.12 years
STANDARD_DEVIATION 2.51 • n=5 Participants
|
10.42 years
STANDARD_DEVIATION 2.41 • n=7 Participants
|
10.00 years
STANDARD_DEVIATION 2.57 • n=5 Participants
|
10.11 years
STANDARD_DEVIATION 2.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
237 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
97 participants
n=5 Participants
|
38 participants
n=7 Participants
|
128 participants
n=5 Participants
|
263 participants
n=4 Participants
|
|
Race/Ethnicity
Caucasian
|
90 participants
n=5 Participants
|
36 participants
n=7 Participants
|
124 participants
n=5 Participants
|
250 participants
n=4 Participants
|
|
Race/Ethnicity
Hispanic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity
African
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity
Native American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity
East Asian
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Child Health and Illness Profile - Child Edition (CHIP-CE) - Achievement Domain
Achievement Domain (N=96, N=33, N=121)
|
29.27 T-Score
STANDARD_DEVIATION 7.89 • n=5 Participants
|
27.72 T-Score
STANDARD_DEVIATION 7.73 • n=7 Participants
|
25.83 T-Score
STANDARD_DEVIATION 7.60 • n=5 Participants
|
27.40 T-Score
STANDARD_DEVIATION 7.86 • n=4 Participants
|
|
Child Health and Illness Profile - Child Edition (CHIP-CE) - Achievement Domain
Satisfaction Domain (N=96, N=24, N=122)
|
39.26 T-Score
STANDARD_DEVIATION 13.89 • n=5 Participants
|
30.11 T-Score
STANDARD_DEVIATION 14.83 • n=7 Participants
|
31.69 T-Score
STANDARD_DEVIATION 14.78 • n=5 Participants
|
34.34 T-Score
STANDARD_DEVIATION 14.91 • n=4 Participants
|
|
Child Health and Illness Profile - Child Edition (CHIP-CE) - Achievement Domain
Comfort Domain (N=96, N=35, N=122)
|
51.31 T-Score
STANDARD_DEVIATION 9.40 • n=5 Participants
|
46.76 T-Score
STANDARD_DEVIATION 12.28 • n=7 Participants
|
44.74 T-Score
STANDARD_DEVIATION 9.38 • n=5 Participants
|
47.51 T-Score
STANDARD_DEVIATION 10.26 • n=4 Participants
|
|
Child Health and Illness Profile - Child Edition (CHIP-CE) - Achievement Domain
Resilience Domain (N=96, N=34, N=123)
|
39.34 T-Score
STANDARD_DEVIATION 10.15 • n=5 Participants
|
34.96 T-Score
STANDARD_DEVIATION 10.89 • n=7 Participants
|
31.40 T-Score
STANDARD_DEVIATION 11.85 • n=5 Participants
|
34.89 T-Score
STANDARD_DEVIATION 11.65 • n=4 Participants
|
|
Child Health and Illness Profile - Child Edition (CHIP-CE) - Achievement Domain
Risk Avoidance (N=96, N=33, N=121)
|
32.03 T-Score
STANDARD_DEVIATION 9.7 • n=5 Participants
|
30.48 T-Score
STANDARD_DEVIATION 12.29 • n=7 Participants
|
22.85 T-Score
STANDARD_DEVIATION 12.00 • n=5 Participants
|
27.38 T-Score
STANDARD_DEVIATION 12.01 • n=4 Participants
|
|
Children's Depression Rating Scale-Revised (CDRS-R)
|
37.93 units on a scale
STANDARD_DEVIATION 12.26 • n=5 Participants
|
43.76 units on a scale
STANDARD_DEVIATION 13.48 • n=7 Participants
|
43.06 units on a scale
STANDARD_DEVIATION 13.69 • n=5 Participants
|
41.26 units on a scale
STANDARD_DEVIATION 13.35 • n=4 Participants
|
|
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S)
|
4.64 units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
4.97 units on a scale
STANDARD_DEVIATION 0.79 • n=7 Participants
|
4.98 units on a scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
4.85 units on a scale
STANDARD_DEVIATION 0.80 • n=4 Participants
|
|
Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S)
Oppositional
|
5.97 units on a scale
STANDARD_DEVIATION 4.93 • n=5 Participants
|
4.97 units on a scale
STANDARD_DEVIATION 4.66 • n=7 Participants
|
8.62 units on a scale
STANDARD_DEVIATION 4.83 • n=5 Participants
|
7.10 units on a scale
STANDARD_DEVIATION 5.05 • n=4 Participants
|
|
Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S)
Cognitive Problems
|
7.86 units on a scale
STANDARD_DEVIATION 3.73 • n=5 Participants
|
7.68 units on a scale
STANDARD_DEVIATION 3.80 • n=7 Participants
|
7.96 units on a scale
STANDARD_DEVIATION 3.61 • n=5 Participants
|
7.88 units on a scale
STANDARD_DEVIATION 3.67 • n=4 Participants
|
|
Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S)
Hyperactivity
|
11.38 units on a scale
STANDARD_DEVIATION 6.09 • n=5 Participants
|
12.03 units on a scale
STANDARD_DEVIATION 5.21 • n=7 Participants
|
14.67 units on a scale
STANDARD_DEVIATION 5.15 • n=5 Participants
|
13.05 units on a scale
STANDARD_DEVIATION 5.74 • n=4 Participants
|
|
Conners' Teacher Rating Scale-Revised:Short Form (CTRS-R:S)
ADHD Index
|
22.14 units on a scale
STANDARD_DEVIATION 6.86 • n=5 Participants
|
22.94 units on a scale
STANDARD_DEVIATION 6.01 • n=7 Participants
|
25.18 units on a scale
STANDARD_DEVIATION 6.07 • n=5 Participants
|
23.70 units on a scale
STANDARD_DEVIATION 6.52 • n=4 Participants
|
|
Pediatric Anxiety Rating Scale (PARS)
|
2.50 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
7.50 units on a scale
STANDARD_DEVIATION 5.68 • n=7 Participants
|
4.67 units on a scale
STANDARD_DEVIATION 5.12 • n=5 Participants
|
4.28 units on a scale
STANDARD_DEVIATION 4.76 • n=4 Participants
|
|
Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV)
Inattention Subscale (N=97, N=38, N=127)
|
20.28 units on a scale
STANDARD_DEVIATION 4.19 • n=5 Participants
|
21.03 units on a scale
STANDARD_DEVIATION 3.72 • n=7 Participants
|
21.87 units on a scale
STANDARD_DEVIATION 3.48 • n=5 Participants
|
21.16 units on a scale
STANDARD_DEVIATION 3.85 • n=4 Participants
|
|
Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV)
Hyperactivity/Impulsivity Subscale (N=97, N=38, N=
|
17.21 units on a scale
STANDARD_DEVIATION 6.10 • n=5 Participants
|
19.66 units on a scale
STANDARD_DEVIATION 5.54 • n=7 Participants
|
21.04 units on a scale
STANDARD_DEVIATION 3.48 • n=5 Participants
|
19.42 units on a scale
STANDARD_DEVIATION 5.19 • n=4 Participants
|
|
Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV)
Combined Type Subscale (N=97, N=38, N=127)
|
37.48 units on a scale
STANDARD_DEVIATION 7.78 • n=5 Participants
|
40.68 units on a scale
STANDARD_DEVIATION 7.87 • n=7 Participants
|
42.91 units on a scale
STANDARD_DEVIATION 5.51 • n=5 Participants
|
40.58 units on a scale
STANDARD_DEVIATION 7.20 • n=4 Participants
|
|
Swanson, Nolan, and Pelham Rating Scale Revised (SNAP-IV)
Oppositional Subscale (N=97, N=38, N=127)
|
10.15 units on a scale
STANDARD_DEVIATION 4.54 • n=5 Participants
|
12.32 units on a scale
STANDARD_DEVIATION 4.67 • n=7 Participants
|
17.99 units on a scale
STANDARD_DEVIATION 3.57 • n=5 Participants
|
14.27 units on a scale
STANDARD_DEVIATION 5.51 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. Achievement Domain Range = -3.1 to 67.7. Higher scores mean greater health or level of functioning in achievement.
Outcome measures
| Measure |
Pure ADHD
n=83 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=28 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=97 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE), Achievement Domain
|
2.65 T-Score
Interval 0.93 to 4.37
|
0.51 T-Score
Interval -1.38 to 2.39
|
3.89 T-Score
Interval 2.22 to 5.57
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9: total score=0-27) and hyperactivity/impulsivity (items #11-#19: total score=0-27). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total combined type (inattention plus hyperactivity/impulsivity) subscale scores range from 0 to 54.
Outcome measures
| Measure |
Pure ADHD
n=90 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=33 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=111 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Inattention Subscale
|
-5.88 units on a scale
Interval -6.97 to -4.78
|
-5.52 units on a scale
Interval -7.34 to -3.69
|
-7.58 units on a scale
Interval -8.69 to -6.46
|
|
Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Hyperactivity/Impulsivity Subscale
|
-6.19 units on a scale
Interval -7.25 to -5.13
|
-5.67 units on a scale
Interval -7.41 to -3.92
|
-8.08 units on a scale
Interval -9.09 to -7.07
|
|
Change From Baseline to 12 Week Endpoint in the Attention-Deficit/Hyperactivity Disorder (ADHD) Subscales of 18-Item Swanson, Nolan and Pelham Rating Scale (SNAP-IV)
Combined Type (ADHD) Subscale
|
-12.1 units on a scale
Interval -13.9 to -10.3
|
-11.2 units on a scale
Interval -14.4 to -7.92
|
-15.7 units on a scale
Interval -17.6 to -13.7
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Outcome measures
| Measure |
Pure ADHD
n=88 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=32 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=112 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S)
|
-1.23 units on a scale
Interval -1.46 to -0.99
|
-1.63 units on a scale
Interval -1.99 to -1.26
|
-1.42 units on a scale
Interval -1.63 to -1.21
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains having a mean score of 50 and standard deviation of 10. Satisfaction range=-25.7 to 66.3; Comfort=-28.6 to 67.2; Resilience=-36.3 to 71.8; Risk Avoidance=-23.5 to 62.5. Higher scores mean greater health or level of functioning in that domain.
Outcome measures
| Measure |
Pure ADHD
n=97 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=38 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=128 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Satisfaction Domain (N=88, N=31, N=105)
|
2.14 T-Score
Interval -0.06 to 4.34
|
0.81 T-Score
Interval -3.33 to 4.95
|
3.78 T-Score
Interval 1.18 to 6.39
|
|
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Comfort Domain (N=86, N=28, N=103)
|
1.01 T-Score
Interval -0.88 to 2.9
|
5.72 T-Score
Interval 1.24 to 10.19
|
4.94 T-Score
Interval 3.14 to 6.73
|
|
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Resilience Domain (N=87, N=30, N=106)
|
1.21 T-Score
Interval -0.85 to 3.27
|
2.18 T-Score
Interval -1.31 to 5.67
|
3.07 T-Score
Interval 1.1 to 5.03
|
|
Change From Baseline to 12 Week Endpoint in CHIP-CE Satisfaction, Comfort, Resilience and Risk Avoidance Domains
Risk Avoidance Domain (N=82, N=28, N=94)
|
4.72 T-Score
Interval 2.93 to 6.51
|
5.70 T-Score
Interval 1.96 to 9.45
|
9.88 T-Score
Interval 7.88 to 11.88
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
The Pediatric Anxiety Rating Scale (PARS) is used to rate the severity of anxiety in children and adolescents, ages 6 to 17 years. The total score for the PARS is derived by summing 5 of the 7 severity/impairment/interference items (2,3,5,6,7). The total score ranges from 0 (none) to 25 (extreme severity). Items 1 (overall number of anxiety symptoms) and 4 (overall severity of physical symptoms) are not included in the total score calculation.
Outcome measures
| Measure |
Pure ADHD
n=89 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=33 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=112 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Pediatric Anxiety Rating Scale (PARS)
|
-0.18 units on a scale
Interval -0.7 to 0.34
|
-1.88 units on a scale
Interval -3.4 to -0.36
|
-1.18 units on a scale
Interval -1.9 to -0.46
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.
Outcome measures
| Measure |
Pure ADHD
n=97 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=38 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=128 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Children's Depression Rating Scale-Revised (CDRS-R)
|
-1.60 units on a scale
Interval -3.54 to 0.34
|
-2.56 units on a scale
Interval -6.38 to 1.25
|
-3.13 units on a scale
Interval -4.64 to -1.62
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
Items are included from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Oppositional Defiant Disorder. The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.
Outcome measures
| Measure |
Pure ADHD
n=90 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=33 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=111 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in SNAP-IV Oppositional Scale
|
-2.01 units on a scale
Interval -2.86 to -1.16
|
-2.12 units on a scale
Interval -3.95 to -0.29
|
-5.54 units on a scale
Interval -6.43 to -4.65
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of adolescent patients with baseline and at least one nonmissing post-baseline measurement.
Parent-completed ASI-4 contains 120 items on 18 emotional and behavioral disorders in adolescents (12-18 years old). Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18); K=Major Depressive (0-42); L=Bipolar (0-27); M=Anorexia (0-12); N=Bulimia (0-12); O=Substance Abuse (0-18).
Outcome measures
| Measure |
Pure ADHD
n=26 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=10 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=30 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category E - Change from Baseline
|
-0.38 units on a scale
Standard Deviation 4.01
|
-4.50 units on a scale
Standard Deviation 8.72
|
-1.30 units on a scale
Standard Deviation 2.35
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category A - Baseline
|
32.73 units on a scale
Standard Deviation 11.42
|
38.33 units on a scale
Standard Deviation 10.32
|
38.13 units on a scale
Standard Deviation 8.30
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category A - Change from Baseline
|
-11.4 units on a scale
Standard Deviation 9.88
|
-10.4 units on a scale
Standard Deviation 11.55
|
-11.6 units on a scale
Standard Deviation 9.50
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category B - Baseline
|
4.04 units on a scale
Standard Deviation 4.25
|
6.00 units on a scale
Standard Deviation 5.62
|
10.80 units on a scale
Standard Deviation 5.41
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category B - Change from Baseline
|
-0.73 units on a scale
Standard Deviation 2.92
|
-0.60 units on a scale
Standard Deviation 5.83
|
-5.57 units on a scale
Standard Deviation 5.58
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category C- Baseline
|
7.92 units on a scale
Standard Deviation 4.77
|
10.50 units on a scale
Standard Deviation 3.72
|
15.60 units on a scale
Standard Deviation 5.24
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category C - Change from Baseline
|
-0.88 units on a scale
Standard Deviation 3.85
|
-1.40 units on a scale
Standard Deviation 6.15
|
-5.47 units on a scale
Standard Deviation 5.51
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category D- Baseline
|
4.73 units on a scale
Standard Deviation 3.14
|
9.20 units on a scale
Standard Deviation 3.58
|
8.37 units on a scale
Standard Deviation 3.54
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category D - Change from Baseline
|
-0.58 units on a scale
Standard Deviation 3.09
|
-1.70 units on a scale
Standard Deviation 3.65
|
-2.97 units on a scale
Standard Deviation 3.67
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category E- Baseline
|
3.58 units on a scale
Standard Deviation 4.00
|
7.60 units on a scale
Standard Deviation 7.85
|
3.63 units on a scale
Standard Deviation 3.16
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category F- Baseline
|
1.19 units on a scale
Standard Deviation 1.27
|
2.60 units on a scale
Standard Deviation 1.43
|
1.20 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category F - Change from Baseline
|
-0.58 units on a scale
Standard Deviation 0.81
|
-1.40 units on a scale
Standard Deviation 1.43
|
-0.53 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category G- Baseline
|
2.27 units on a scale
Standard Deviation 3.50
|
4.50 units on a scale
Standard Deviation 5.25
|
2.10 units on a scale
Standard Deviation 2.63
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category G - Change from Baseline
|
-0.46 units on a scale
Standard Deviation 2.49
|
-3.20 units on a scale
Standard Deviation 4.71
|
-0.97 units on a scale
Standard Deviation 2.40
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category H- Baseline
|
0.73 units on a scale
Standard Deviation 1.28
|
1.60 units on a scale
Standard Deviation 2.27
|
1.70 units on a scale
Standard Deviation 1.74
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category H - Change from Baseline
|
-0.38 units on a scale
Standard Deviation 1.20
|
0.20 units on a scale
Standard Deviation 2.86
|
-0.67 units on a scale
Standard Deviation 1.69
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category I- Baseline
|
1.00 units on a scale
Standard Deviation 1.92
|
3.20 units on a scale
Standard Deviation 3.65
|
2.13 units on a scale
Standard Deviation 2.22
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category I - Change from Baseline
|
-0.19 units on a scale
Standard Deviation 0.80
|
-1.30 units on a scale
Standard Deviation 3.89
|
-0.93 units on a scale
Standard Deviation 1.70
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category J- Baseline
|
0.42 units on a scale
Standard Deviation 0.99
|
0.40 units on a scale
Standard Deviation 0.97
|
0.50 units on a scale
Standard Deviation 0.78
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category J - Change from Baseline
|
0.00 units on a scale
Standard Deviation 0.69
|
-0.30 units on a scale
Standard Deviation 0.67
|
-0.23 units on a scale
Standard Deviation 0.43
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category K- Baseline
|
3.73 units on a scale
Standard Deviation 3.99
|
4.90 units on a scale
Standard Deviation 2.85
|
4.23 units on a scale
Standard Deviation 4.05
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category N - Change from Baseline
|
-0.38 units on a scale
Standard Deviation 1.70
|
-0.90 units on a scale
Standard Deviation 2.23
|
-0.80 units on a scale
Standard Deviation 1.49
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category L- Baseline
|
3.54 units on a scale
Standard Deviation 4.68
|
5.10 units on a scale
Standard Deviation 5.00
|
6.03 units on a scale
Standard Deviation 5.02
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category L - Change from Baseline
|
-1.08 units on a scale
Standard Deviation 3.46
|
-0.20 units on a scale
Standard Deviation 6.03
|
-1.97 units on a scale
Standard Deviation 4.30
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category K - Change from Baseline
|
-1.04 units on a scale
Standard Deviation 2.90
|
-1.00 units on a scale
Standard Deviation 3.50
|
-1.60 units on a scale
Standard Deviation 3.50
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category M- Baseline
|
0.73 units on a scale
Standard Deviation 1.22
|
1.30 units on a scale
Standard Deviation 2.06
|
0.50 units on a scale
Standard Deviation 1.41
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category M - Change from Baseline
|
0.15 units on a scale
Standard Deviation 1.08
|
-0.10 units on a scale
Standard Deviation 3.21
|
0.30 units on a scale
Standard Deviation 1.39
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category N- Baseline
|
1.31 units on a scale
Standard Deviation 1.54
|
2.20 units on a scale
Standard Deviation 3.05
|
2.30 units on a scale
Standard Deviation 1.84
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category O- Baseline
|
0.23 units on a scale
Standard Deviation 0.71
|
0.30 units on a scale
Standard Deviation 0.95
|
0.53 units on a scale
Standard Deviation 0.97
|
|
Change From Baseline to 12 Week Endpoint in Adolescent Symptom Inventory-4: Parent Checklist (ASI-4)
Category O - Change from Baseline
|
0.15 units on a scale
Standard Deviation 0.37
|
-0.20 units on a scale
Standard Deviation 0.63
|
-0.13 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of child patients with baseline and at least one nonmissing post-baseline measurement.
The CSI-4 contains 97 items that screen for 15 emotional and behavioral disorders in children between 5 and 12 years old. Item score range:0 (no symptoms) to 3 (maximum impairment). Categories: A=ADHD (0-54); B=Conduct (0-60); C=Oppositional Defiant (0-24); D=Generalized Anxiety (0-18); E=Specific Phobia/Panic Attack/Obsessions/Compulsions/Somatization (0-30); F=Social Phobia (0-6); G=Separation Anxiety (0-24); H=Schizoid Personality (0-9); I=Schizophrenia (0-6); J=Enuresis (0-18).
Outcome measures
| Measure |
Pure ADHD
n=58 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=22 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=78 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category A - Baseline
|
34.00 units on a scale
Standard Deviation 10.43
|
36.00 units on a scale
Standard Deviation 9.32
|
38.95 units on a scale
Standard Deviation 8.68
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category D - Change from Baseline
|
-0.84 units on a scale
Standard Deviation 3.16
|
-2.23 units on a scale
Standard Deviation 3.01
|
-1.63 units on a scale
Standard Deviation 3.86
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category H - Change from Baseline
|
-1.10 units on a scale
Standard Deviation 2.21
|
-1.09 units on a scale
Standard Deviation 2.93
|
-1.54 units on a scale
Standard Deviation 4.31
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category A - Change from Baseline
|
-10.6 units on a scale
Standard Deviation 9.76
|
-9.68 units on a scale
Standard Deviation 9.54
|
-12.7 units on a scale
Standard Deviation 12.06
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category B - Baseline
|
9.29 units on a scale
Standard Deviation 4.72
|
11.05 units on a scale
Standard Deviation 4.13
|
15.65 units on a scale
Standard Deviation 4.40
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category B - Change from Baseline
|
-2.12 units on a scale
Standard Deviation 3.88
|
-1.14 units on a scale
Standard Deviation 5.25
|
-3.76 units on a scale
Standard Deviation 5.56
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category C - Baseline
|
2.10 units on a scale
Standard Deviation 2.44
|
2.23 units on a scale
Standard Deviation 2.25
|
4.63 units on a scale
Standard Deviation 3.69
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category C - Change from Baseline
|
-0.88 units on a scale
Standard Deviation 2.11
|
-0.05 units on a scale
Standard Deviation 3.06
|
-1.99 units on a scale
Standard Deviation 3.17
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category D - Baseline
|
5.83 units on a scale
Standard Deviation 3.37
|
8.23 units on a scale
Standard Deviation 3.96
|
7.41 units on a scale
Standard Deviation 3.94
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category E - Baseline
|
2.07 units on a scale
Standard Deviation 1.87
|
2.09 units on a scale
Standard Deviation 1.95
|
2.79 units on a scale
Standard Deviation 2.69
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category E - Change from Baseline
|
-0.38 units on a scale
Standard Deviation 1.90
|
-0.41 units on a scale
Standard Deviation 1.74
|
-0.85 units on a scale
Standard Deviation 2.43
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category F - Baseline
|
0.48 units on a scale
Standard Deviation 0.86
|
0.32 units on a scale
Standard Deviation 0.57
|
0.91 units on a scale
Standard Deviation 1.35
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category F - Change from Baseline
|
-0.17 units on a scale
Standard Deviation 0.94
|
-0.14 units on a scale
Standard Deviation 0.64
|
-0.24 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category G - Baseline
|
3.02 units on a scale
Standard Deviation 2.70
|
4.05 units on a scale
Standard Deviation 2.79
|
3.51 units on a scale
Standard Deviation 3.30
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category G - Change from Baseline
|
-0.62 units on a scale
Standard Deviation 2.40
|
-0.91 units on a scale
Standard Deviation 2.00
|
-0.46 units on a scale
Standard Deviation 2.52
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category H - Baseline
|
3.66 units on a scale
Standard Deviation 4.14
|
4.64 units on a scale
Standard Deviation 4.02
|
4.45 units on a scale
Standard Deviation 4.39
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category I - Baseline
|
2.76 units on a scale
Standard Deviation 1.85
|
2.77 units on a scale
Standard Deviation 1.38
|
2.94 units on a scale
Standard Deviation 1.93
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category I - Change from Baseline
|
-0.03 units on a scale
Standard Deviation 1.83
|
-0.45 units on a scale
Standard Deviation 1.47
|
-0.32 units on a scale
Standard Deviation 1.75
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category J - Baseline
|
3.92 units on a scale
Standard Deviation 3.98
|
5.58 units on a scale
Standard Deviation 6.05
|
5.22 units on a scale
Standard Deviation 4.47
|
|
Change From Baseline to 12 Week Endpoint in Child Symptom Inventory-4: Parent Checklist (CSI-4)
Category J - Change from Baseline
|
-1.34 units on a scale
Standard Deviation 3.64
|
-0.86 units on a scale
Standard Deviation 2.61
|
-1.55 units on a scale
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: Baseline, 12 WeeksPopulation: Number of patients with baseline and at least one nonmissing post-baseline measurement.
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 |
Pure ADHD
n=60 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=15 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=53 Participants
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
Hyperactivity
|
-2.87 units on a scale
Interval -4.04 to -1.69
|
-2.34 units on a scale
Interval -4.8 to 0.11
|
-4.09 units on a scale
Interval -5.52 to -2.67
|
|
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
ADHD Index
|
-4.94 units on a scale
Interval -6.36 to -3.52
|
-3.60 units on a scale
Interval -6.65 to -0.55
|
-6.62 units on a scale
Interval -8.59 to -4.65
|
|
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
Oppositional
|
-1.42 units on a scale
Interval -2.22 to -0.61
|
1.07 units on a scale
Interval -0.33 to 2.46
|
-2.35 units on a scale
Interval -3.55 to -1.15
|
|
Change From Baseline to 12 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form (CTRS-R:S)
Cognitive Problems
|
-1.08 units on a scale
Interval -1.72 to -0.45
|
-0.47 units on a scale
Interval -1.74 to 0.8
|
-0.94 units on a scale
Interval -1.77 to -0.11
|
Adverse Events
Pure ADHD
Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths
ADHD+Internalizing Disorders
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
ADHD+Externalizing Disorders
Serious events: 2 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pure ADHD
n=97 participants at risk
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=38 participants at risk
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=128 participants at risk
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/97
|
0.00%
0/38
|
0.78%
1/128 • Number of events 1
|
|
General disorders
Idiosyncratic drug reaction
|
0.00%
0/97
|
0.00%
0/38
|
0.78%
1/128 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
1.0%
1/97 • Number of events 1
|
0.00%
0/38
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/97
|
0.00%
0/38
|
0.78%
1/128 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/97
|
0.00%
0/38
|
0.78%
1/128 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/97
|
0.00%
0/38
|
0.78%
1/128 • Number of events 1
|
Other adverse events
| Measure |
Pure ADHD
n=97 participants at risk
Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Internalizing Disorders
n=38 participants at risk
Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
ADHD+Externalizing Disorders
n=128 participants at risk
Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.3%
9/97 • Number of events 13
|
21.1%
8/38 • Number of events 9
|
14.1%
18/128 • Number of events 32
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
5/97 • Number of events 5
|
15.8%
6/38 • Number of events 8
|
9.4%
12/128 • Number of events 17
|
|
Gastrointestinal disorders
Constipation
|
2.1%
2/97 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
0.78%
1/128 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
1/97 • Number of events 3
|
5.3%
2/38 • Number of events 2
|
2.3%
3/128 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
12.4%
12/97 • Number of events 17
|
26.3%
10/38 • Number of events 19
|
20.3%
26/128 • Number of events 36
|
|
Gastrointestinal disorders
Vomiting
|
13.4%
13/97 • Number of events 23
|
15.8%
6/38 • Number of events 13
|
11.7%
15/128 • Number of events 20
|
|
General disorders
Asthenia
|
5.2%
5/97 • Number of events 6
|
15.8%
6/38 • Number of events 6
|
5.5%
7/128 • Number of events 7
|
|
General disorders
Fatigue
|
5.2%
5/97 • Number of events 5
|
0.00%
0/38
|
1.6%
2/128 • Number of events 3
|
|
General disorders
Irritability
|
4.1%
4/97 • Number of events 4
|
15.8%
6/38 • Number of events 6
|
9.4%
12/128 • Number of events 16
|
|
General disorders
Pyrexia
|
3.1%
3/97 • Number of events 3
|
0.00%
0/38
|
6.2%
8/128 • Number of events 8
|
|
Infections and infestations
Gastroenteritis
|
2.1%
2/97 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
0.00%
0/128
|
|
Investigations
Weight decreased
|
11.3%
11/97 • Number of events 15
|
2.6%
1/38 • Number of events 1
|
9.4%
12/128 • Number of events 15
|
|
Metabolism and nutrition disorders
Anorexia
|
24.7%
24/97 • Number of events 26
|
28.9%
11/38 • Number of events 15
|
25.8%
33/128 • Number of events 39
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.3%
11/97 • Number of events 13
|
18.4%
7/38 • Number of events 7
|
10.9%
14/128 • Number of events 20
|
|
Nervous system disorders
Headache
|
20.6%
20/97 • Number of events 34
|
26.3%
10/38 • Number of events 17
|
20.3%
26/128 • Number of events 35
|
|
Nervous system disorders
Somnolence
|
22.7%
22/97 • Number of events 23
|
28.9%
11/38 • Number of events 15
|
26.6%
34/128 • Number of events 44
|
|
Psychiatric disorders
Aggression
|
4.1%
4/97 • Number of events 5
|
2.6%
1/38 • Number of events 1
|
7.0%
9/128 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
3/97 • Number of events 3
|
0.00%
0/38
|
6.2%
8/128 • Number of events 10
|
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