Trial Outcomes & Findings for A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents (NCT NCT00447278)
NCT ID: NCT00447278
Last Updated: 2010-04-27
Results Overview
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
399 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2010-04-27
Participant Flow
Study consisted of a 1 week screening (Period I); 6 months open-label (Period II); Optional additional 6 month open-label extension (Period III).
Participant milestones
| Measure |
Atomoxetine
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Period II (6 Month Open-Label)
STARTED
|
199
|
200
|
|
Period II (6 Month Open-Label)
Received at Least One Dose of Study Drug
|
199
|
199
|
|
Period II (6 Month Open-Label)
COMPLETED
|
157
|
171
|
|
Period II (6 Month Open-Label)
NOT COMPLETED
|
42
|
29
|
|
Period III (Optional 6 Month Extension)
STARTED
|
139
|
155
|
|
Period III (Optional 6 Month Extension)
COMPLETED
|
109
|
140
|
|
Period III (Optional 6 Month Extension)
NOT COMPLETED
|
30
|
15
|
Reasons for withdrawal
| Measure |
Atomoxetine
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Period II (6 Month Open-Label)
Adverse Event
|
7
|
3
|
|
Period II (6 Month Open-Label)
Lost to Follow-up
|
0
|
4
|
|
Period II (6 Month Open-Label)
Protocol Violation
|
10
|
7
|
|
Period II (6 Month Open-Label)
Withdrawal by Subject
|
1
|
3
|
|
Period II (6 Month Open-Label)
Physician Decision
|
4
|
1
|
|
Period II (6 Month Open-Label)
Lack of Efficacy
|
11
|
1
|
|
Period II (6 Month Open-Label)
Parent/Guardian Decision
|
9
|
10
|
|
Period III (Optional 6 Month Extension)
Adverse Event
|
2
|
2
|
|
Period III (Optional 6 Month Extension)
Lost to Follow-up
|
2
|
2
|
|
Period III (Optional 6 Month Extension)
Protocol Violation
|
6
|
1
|
|
Period III (Optional 6 Month Extension)
Withdrawal by Subject
|
4
|
1
|
|
Period III (Optional 6 Month Extension)
Physician Decision
|
1
|
1
|
|
Period III (Optional 6 Month Extension)
Lack of Efficacy
|
4
|
0
|
|
Period III (Optional 6 Month Extension)
Parent/Guardian Decision
|
11
|
8
|
Baseline Characteristics
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=199 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
9.2 years
STANDARD_DEVIATION 2.57 • n=5 Participants
|
9.4 years
STANDARD_DEVIATION 2.64 • n=7 Participants
|
9.3 years
STANDARD_DEVIATION 2.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
158 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
180 participants
n=5 Participants
|
181 participants
n=7 Participants
|
361 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
France
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
61 participants
n=5 Participants
|
58 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Affective Disorder
0 Affective Disorders
|
189 participants
n=5 Participants
|
189 participants
n=7 Participants
|
378 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Affective Disorder
1 Affective Disorder
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Affective Disorder
Missing Information
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Anxiety Disorder
0 Anxiety Disorders
|
176 participants
n=5 Participants
|
173 participants
n=7 Participants
|
349 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Anxiety Disorder
1 Anxiety Disorder
|
11 participants
n=5 Participants
|
18 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Anxiety Disorder
2 Anxiety Disorders
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Anxiety Disorder
3 Anxiety Disorders
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Anxiety Disorder
4 Anxiety Disorders
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Anxiety Disorder
Missing Information
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes
Combined ADHD Subtype
|
156 participants
n=5 Participants
|
156 participants
n=7 Participants
|
312 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes
Hyperactive/Impulsive ADHD Subtype
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes
Inattentive ADHD Subtype
|
39 participants
n=5 Participants
|
36 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Conduct Disorder
Yes (currently have the disorder)
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Conduct Disorder
Yes, but not present (had disorder in the past)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Conduct Disorder
No (never had the disorder)
|
184 participants
n=5 Participants
|
187 participants
n=7 Participants
|
371 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder
Yes (currently have the disorder)
|
79 participants
n=5 Participants
|
73 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder
Yes, but not present (had disorder in the past)
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder
No (never had the disorder)
|
118 participants
n=5 Participants
|
122 participants
n=7 Participants
|
240 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Tic Disorder
0 Tic Disorders
|
176 participants
n=5 Participants
|
178 participants
n=7 Participants
|
354 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Tic Disorder
1 Tic Disorder
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Tic Disorder
2 Tic Disorders
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Tic Disorder
3 Tic Disorders
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Kiddie Schedule for Affective Disorders - Tic Disorder
Missing Information
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Age at Onset of Attention-Deficit/Hyperactivity Disorder (ADHD)
|
4.3 years
STANDARD_DEVIATION 1.88 • n=5 Participants
|
4.2 years
STANDARD_DEVIATION 1.91 • n=7 Participants
|
4.2 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
|
Height
|
138.8 centimeters
STANDARD_DEVIATION 14.59 • n=5 Participants
|
140.1 centimeters
STANDARD_DEVIATION 15.71 • n=7 Participants
|
139.4 centimeters
STANDARD_DEVIATION 15.16 • n=5 Participants
|
|
Time Since Onset of ADHD
|
5.0 years
STANDARD_DEVIATION 2.65 • n=5 Participants
|
5.2 years
STANDARD_DEVIATION 2.97 • n=7 Participants
|
5.1 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
|
Weight
|
37.5 kilograms (kg)
STANDARD_DEVIATION 14.30 • n=5 Participants
|
37.6 kilograms (kg)
STANDARD_DEVIATION 13.35 • n=7 Participants
|
37.5 kilograms (kg)
STANDARD_DEVIATION 13.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: Number of participants who received at least one dose of study drug and did not have a missing value. Results for Last Observation Carried Forward (LOCF) are included.
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Outcome measures
| Measure |
Atomoxetine
n=198 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
Baseline (n=198, n=199)
|
28.0 T-Scores of units on a scale
Standard Deviation 12.04
|
28.3 T-Scores of units on a scale
Standard Deviation 12.28
|
|
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
Change from Baseline at 6 Months (n=150, n=166)
|
8.4 T-Scores of units on a scale
Standard Deviation 10.15
|
12.4 T-Scores of units on a scale
Standard Deviation 11.37
|
|
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
Change from Baseline: 6 Month LOCF (n=192,n=195)
|
7.3 T-Scores of units on a scale
Standard Deviation 10.71
|
11.7 T-Scores of units on a scale
Standard Deviation 11.24
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 12 monthsPopulation: Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Outcome measures
| Measure |
Atomoxetine
n=198 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
Change from Baseline: 4 Month LOCF (n=192, n=195)
|
7.8 T-Scores of units on a scale
Standard Deviation 10.84
|
10.7 T-Scores of units on a scale
Standard Deviation 11.32
|
|
Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
Month 6 Baseline (M6B) (n=132, n=148)
|
37.7 T-Scores of units on a scale
Standard Deviation 11.75
|
41.2 T-Scores of units on a scale
Standard Deviation 12.28
|
|
Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
Change from M6B at 12 Months (n=104, n=128)
|
1.2 T-Scores of units on a scale
Standard Deviation 10.60
|
-0.9 T-Scores of units on a scale
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 6 months, 12 monthsPopulation: Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.
CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Outcome measures
| Measure |
Atomoxetine
n=199 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Comfort Baseline (n=198, n=198)
|
43.4 T-Scores of units on a scale
Standard Deviation 11.58
|
43.0 T-Scores of units on a scale
Standard Deviation 11.27
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Comfort Change at 4 Month LOCF (n=191, n=194)
|
1.9 T-Scores of units on a scale
Standard Deviation 10.60
|
5.2 T-Scores of units on a scale
Standard Deviation 11.22
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Comfort Change at 6 Month LOCF (n=191, n=194)
|
2.3 T-Scores of units on a scale
Standard Deviation 11.14
|
4.7 T-Scores of units on a scale
Standard Deviation 11.64
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Comfort Month 6 Baseline (n=137, n=153)
|
46.5 T-Scores of units on a scale
Standard Deviation 10.98
|
47.7 T-Scores of units on a scale
Standard Deviation 9.78
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Comfort Change at 12 Months (n=109, n=134)
|
0.2 T-Scores of units on a scale
Standard Deviation 10.38
|
-0.5 T-Scores of units on a scale
Standard Deviation 10.28
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Resilience Baseline (n=199, n=197)
|
37.8 T-Scores of units on a scale
Standard Deviation 14.59
|
38.9 T-Scores of units on a scale
Standard Deviation 12.63
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Resilience Change at 4 Month LOCF (n=193, n=193)
|
4.9 T-Scores of units on a scale
Standard Deviation 12.19
|
3.8 T-Scores of units on a scale
Standard Deviation 13.38
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Resilience Change at 6 Month LOCF (n=193, n=193)
|
5.0 T-Scores of units on a scale
Standard Deviation 12.86
|
5.5 T-Scores of units on a scale
Standard Deviation 12.99
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Resilience Month 6 Baseline (n=136, n=152)
|
44.3 T-Scores of units on a scale
Standard Deviation 14.78
|
45.3 T-Scores of units on a scale
Standard Deviation 14.08
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Resilience Change at 12 Months (n=109, n=133)
|
-1.6 T-Scores of units on a scale
Standard Deviation 12.38
|
-0.3 T-Scores of units on a scale
Standard Deviation 11.98
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Risk Avoidance Baseline (n=198, n=198)
|
29.7 T-Scores of units on a scale
Standard Deviation 20.18
|
31.2 T-Scores of units on a scale
Standard Deviation 20.14
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Risk Avoidance Change: 4 Month LOCF (n=192, n=194)
|
9.0 T-Scores of units on a scale
Standard Deviation 13.63
|
9.3 T-Scores of units on a scale
Standard Deviation 14.20
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Risk Avoidance Change: 6 Month LOCF (n=192, n=194)
|
8.0 T-Scores of units on a scale
Standard Deviation 12.90
|
9.6 T-Scores of units on a scale
Standard Deviation 15.16
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Risk Avoidance Month 6 Baseline (n=132, n=149)
|
40.1 T-Scores of units on a scale
Standard Deviation 16.45
|
41.1 T-Scores of units on a scale
Standard Deviation 16.23
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Risk Avoidance Change at 12 Months (n=104, n=130)
|
1.0 T-Scores of units on a scale
Standard Deviation 10.98
|
2.2 T-Scores of units on a scale
Standard Deviation 10.25
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Satisfaction Baseline (n=199, n=198)
|
33.4 T-Scores of units on a scale
Standard Deviation 16.16
|
32.8 T-Scores of units on a scale
Standard Deviation 16.29
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Satisfaction Change at 4 Month LOCF (n=193, n=194)
|
3.1 T-Scores of units on a scale
Standard Deviation 13.53
|
6.9 T-Scores of units on a scale
Standard Deviation 16.18
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Satisfaction Change at 6 Month LOCF (n=193, n=194)
|
4.1 T-Scores of units on a scale
Standard Deviation 13.51
|
7.2 T-Scores of units on a scale
Standard Deviation 15.94
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Satisfaction Month 6 Baseline (n=138, n=153)
|
39.6 T-Scores of units on a scale
Standard Deviation 15.73
|
40.7 T-Scores of units on a scale
Standard Deviation 16.17
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Satisfaction Change at 12 Months (n=110, n=134)
|
-0.9 T-Scores of units on a scale
Standard Deviation 14.14
|
1.0 T-Scores of units on a scale
Standard Deviation 10.96
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 6 months, 12 monthsPopulation: Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.
The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0="never or not at all", 1="sometimes or somewhat", 2="often or much", 3="very often or very much"). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).
Outcome measures
| Measure |
Atomoxetine
n=199 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Total Baseline (n=192, n=194)
|
1.02 units on a scale
Standard Deviation 0.475
|
0.96 units on a scale
Standard Deviation 0.453
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Total Change at 4 Months LOCF (n=187, n=190)
|
-0.30 units on a scale
Standard Deviation 0.328
|
-0.35 units on a scale
Standard Deviation 0.357
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Total Change at 6 Month LOCF (n=187, n=190)
|
-0.30 units on a scale
Standard Deviation 0.333
|
-0.36 units on a scale
Standard Deviation 0.363
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Total 6 Month Baseline (n=134, n=150)
|
0.62 units on a scale
Standard Deviation 0.356
|
0.59 units on a scale
Standard Deviation 0.344
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Total Change at 12 Months (n=103, n=126)
|
-0.01 units on a scale
Standard Deviation 0.247
|
-0.02 units on a scale
Standard Deviation 0.252
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Home Baseline (n=196, n=199)
|
1.28 units on a scale
Standard Deviation 0.777
|
1.19 units on a scale
Standard Deviation 0.728
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Home Change at 4 Month LOCF (n=190, n=195)
|
-0.40 units on a scale
Standard Deviation 0.608
|
-0.45 units on a scale
Standard Deviation 0.591
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Home Change at 6 Month LOCF (n=190, n=195)
|
-0.40 units on a scale
Standard Deviation 0.590
|
-0.44 units on a scale
Standard Deviation 0.599
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Home 6 Month Baseline (n=139, n=152)
|
0.74 units on a scale
Standard Deviation 0.592
|
0.72 units on a scale
Standard Deviation 0.557
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Home Change at 12 Months (n=109, n=131)
|
0.01 units on a scale
Standard Deviation 0.414
|
-0.04 units on a scale
Standard Deviation 0.440
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Daily Living Baseline (n=197, n=196)
|
1.06 units on a scale
Standard Deviation 0.559
|
1.07 units on a scale
Standard Deviation 0.519
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Daily Living Change at 4 Month LOCF (n=191, n=192)
|
-0.20 units on a scale
Standard Deviation 0.477
|
-0.25 units on a scale
Standard Deviation 0.427
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Daily Living Change at 6 Month LOCF (n=191, n=192)
|
-0.20 units on a scale
Standard Deviation 0.467
|
-0.27 units on a scale
Standard Deviation 0.427
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Daily Living 6 Month Baseline (n=139, n=152)
|
0.82 units on a scale
Standard Deviation 0.445
|
0.81 units on a scale
Standard Deviation 0.429
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Daily Living Change at 12 Months (n=108, n=131)
|
-0.04 units on a scale
Standard Deviation 0.334
|
-0.03 units on a scale
Standard Deviation 0.365
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Risk Taking Baseline (n=198, n=199)
|
0.51 units on a scale
Standard Deviation 0.424
|
0.45 units on a scale
Standard Deviation 0.383
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Risk Taking Change at 4 Month LOCF (n=192, n=195)
|
-0.16 units on a scale
Standard Deviation 0.277
|
-0.17 units on a scale
Standard Deviation 0.272
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Risk Taking Change at 6 Month LOCF (n=192, n=195)
|
-0.17 units on a scale
Standard Deviation 0.285
|
-0.18 units on a scale
Standard Deviation 0.269
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Risk Taking 6 Month Baseline (n=139, n=151)
|
0.29 units on a scale
Standard Deviation 0.312
|
0.25 units on a scale
Standard Deviation 0.302
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Risk Taking Change at 12 Months (n=109, n=130)
|
-0.01 units on a scale
Standard Deviation 0.199
|
-0.02 units on a scale
Standard Deviation 0.207
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
School Baseline (n=198, n=199)
|
1.24 units on a scale
Standard Deviation 0.592
|
1.18 units on a scale
Standard Deviation 0.617
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
School Change at 4 Month LOCF (n=192, n=195)
|
-0.49 units on a scale
Standard Deviation 0.504
|
-0.57 units on a scale
Standard Deviation 0.563
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
School Change at 6 Month LOCF (n=192, n=195)
|
-0.49 units on a scale
Standard Deviation 0.523
|
-0.60 units on a scale
Standard Deviation 0.565
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
School 6 Month Baseline (n=138, n=152)
|
0.62 units on a scale
Standard Deviation 0.459
|
0.53 units on a scale
Standard Deviation 0.444
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
School Change at 12 Months (n=107, n=132)
|
-0.03 units on a scale
Standard Deviation 0.455
|
-0.03 units on a scale
Standard Deviation 0.389
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Self-Concept Baseline (n=198, n=198)
|
0.94 units on a scale
Standard Deviation 0.787
|
0.85 units on a scale
Standard Deviation 0.726
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Self-Concept Change at 4 Month LOCF (n=192, n=194)
|
-0.25 units on a scale
Standard Deviation 0.738
|
-0.31 units on a scale
Standard Deviation 0.723
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Self-Concept Change at 6 Month LOCF (n=192, n=194)
|
-0.27 units on a scale
Standard Deviation 0.758
|
-0.32 units on a scale
Standard Deviation 0.728
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Self-Concept 6 Month Baseline (n=137, n=132)
|
0.55 units on a scale
Standard Deviation 0.574
|
0.50 units on a scale
Standard Deviation 0.538
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Self-Concept Change at 12 Months (n=107, n=131)
|
0.02 units on a scale
Standard Deviation 0.615
|
0.02 units on a scale
Standard Deviation 0.529
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Social Baseline (n=198, n=198)
|
1.02 units on a scale
Standard Deviation 0.661
|
0.97 units on a scale
Standard Deviation 0.602
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Social Change at 4 Month LOCF (n=192, n=194)
|
-0.26 units on a scale
Standard Deviation 0.491
|
-0.32 units on a scale
Standard Deviation 0.513
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Social Change at 6 Month LOCF (n=192, n=194)
|
-0.28 units on a scale
Standard Deviation 0.536
|
-0.30 units on a scale
Standard Deviation 0.521
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Social 6 Month Baseline (n=139, n=152)
|
0.64 units on a scale
Standard Deviation 0.491
|
0.67 units on a scale
Standard Deviation 0.499
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Social Change at 12 Months (n=109, n=132)
|
-0.02 units on a scale
Standard Deviation 0.405
|
-0.03 units on a scale
Standard Deviation 0.371
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 6 months, 12 monthsPopulation: Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.
Outcome measures
| Measure |
Atomoxetine
n=199 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Total Baseline (n=199, n=198)
|
40.87 units on a scale
Standard Deviation 8.674
|
40.35 units on a scale
Standard Deviation 8.818
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Total Change at 4 Month LOCF (n=193, n=194)
|
-18.1 units on a scale
Standard Deviation 11.726
|
-20.1 units on a scale
Standard Deviation 11.562
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Total Change at 6 Month LOCF (n=193, n=194)
|
-17.6 units on a scale
Standard Deviation 11.688
|
-20.3 units on a scale
Standard Deviation 11.397
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Total 6 Month Baseline (n=137, n=154)
|
20.84 units on a scale
Standard Deviation 10.923
|
18.62 units on a scale
Standard Deviation 10.255
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Total Change at 12 Months (n=108, n=138)
|
-2.35 units on a scale
Standard Deviation 9.393
|
-2.71 units on a scale
Standard Deviation 8.998
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Inattention Baseline (n=199, n=198)
|
21.91 units on a scale
Standard Deviation 4.138
|
21.55 units on a scale
Standard Deviation 4.373
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Inattention Change at 4 Month LOCF (n=193, n=194)
|
-9.58 units on a scale
Standard Deviation 6.510
|
-11.1 units on a scale
Standard Deviation 6.150
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Inattention Change at 6 Month LOCF (n=193, n=194)
|
-9.15 units on a scale
Standard Deviation 6.544
|
-11.2 units on a scale
Standard Deviation 6.339
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Inattention 6 Month Baseline (n=137, n=154)
|
11.52 units on a scale
Standard Deviation 5.936
|
9.51 units on a scale
Standard Deviation 5.510
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Inattention Change at 12 Months (n=108, n=139)
|
-1.17 units on a scale
Standard Deviation 5.359
|
-1.13 units on a scale
Standard Deviation 5.273
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Hyperactivity Baseline (n=199, n=198)
|
18.97 units on a scale
Standard Deviation 6.082
|
18.80 units on a scale
Standard Deviation 6.252
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Hyperactivity Change at 4 Month LOCF (n=193,n=194)
|
-8.54 units on a scale
Standard Deviation 6.166
|
-8.97 units on a scale
Standard Deviation 6.572
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Hyperactivity Change at 6 Month LOCF (n=193,n=194)
|
-8.42 units on a scale
Standard Deviation 6.189
|
-9.13 units on a scale
Standard Deviation 6.255
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Hyperactivity 6 Month Baseline (n=138, n=154)
|
9.36 units on a scale
Standard Deviation 5.972
|
9.11 units on a scale
Standard Deviation 5.770
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Hyperactivity Change at 12 Months (n=109, n=138)
|
-1.24 units on a scale
Standard Deviation 4.965
|
-1.63 units on a scale
Standard Deviation 4.644
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 6 months, 12 monthsPopulation: Number of participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 139, OEST n=155). Their data at 6 months was taken as baseline for the 12 month change.
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 |
Atomoxetine
n=199 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
Baseline (n=199, n=199)
|
5.54 units on a scale
Standard Deviation 0.857
|
5.45 units on a scale
Standard Deviation 0.903
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
Change at 4 Month LOCF (n=199, n=199)
|
-1.88 units on a scale
Standard Deviation 1.252
|
-1.94 units on a scale
Standard Deviation 1.228
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
Change at 6 Month LOCF (n=199, n=199)
|
-1.94 units on a scale
Standard Deviation 1.351
|
-2.06 units on a scale
Standard Deviation 1.323
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
6 Month Baseline (n=138, n=153)
|
3.21 units on a scale
Standard Deviation 1.104
|
3.17 units on a scale
Standard Deviation 1.229
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
Change at 12 Months (n=109, n=137)
|
-0.28 units on a scale
Standard Deviation 1.037
|
-0.57 units on a scale
Standard Deviation 0.953
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 6 months, 12 monthsPopulation: Number of "child" participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n= 112, OEST n=124). Their data at 6 months was taken as baseline for the 12 month change.
CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Outcome measures
| Measure |
Atomoxetine
n=160 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=156 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Resilience Baseline (n=159, n=155)
|
46.1 T-Scores of units on a scale
Standard Deviation 12.13
|
46.0 T-Scores of units on a scale
Standard Deviation 11.12
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Achievement Baseline (n=157, n=155)
|
35.8 T-Scores of units on a scale
Standard Deviation 14.15
|
36.5 T-Scores of units on a scale
Standard Deviation 13.03
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Achievement Change at 4 Month LOCF (n=139, n=135)
|
4.6 T-Scores of units on a scale
Standard Deviation 12.29
|
7.0 T-Scores of units on a scale
Standard Deviation 12.38
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Achievement Change at 6 Month LOCF (n=145, n=142)
|
5.1 T-Scores of units on a scale
Standard Deviation 12.82
|
8.8 T-Scores of units on a scale
Standard Deviation 12.19
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Achievement 6 Month Baseline (n=108, n=117)
|
43.8 T-Scores of units on a scale
Standard Deviation 13.66
|
46.3 T-Scores of units on a scale
Standard Deviation 12.50
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Achievement Change at 12 Months (n=87, n=105)
|
-0.5 T-Scores of units on a scale
Standard Deviation 9.71
|
-0.1 T-Scores of units on a scale
Standard Deviation 11.19
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Comfort Baseline (n=159, n=155)
|
49.1 T-Scores of units on a scale
Standard Deviation 10.39
|
48.2 T-Scores of units on a scale
Standard Deviation 9.20
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Comfort Change at 4 Month LOCF (n=146, n=140)
|
2.8 T-Scores of units on a scale
Standard Deviation 9.25
|
5.2 T-Scores of units on a scale
Standard Deviation 8.74
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Comfort Change at 6 Month LOCF (n=147, n=143)
|
3.1 T-Scores of units on a scale
Standard Deviation 9.72
|
6.3 T-Scores of units on a scale
Standard Deviation 9.14
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Comfort 6 Month Baseline (n=108, n=122)
|
52.2 T-Scores of units on a scale
Standard Deviation 8.43
|
54.0 T-Scores of units on a scale
Standard Deviation 8.15
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Comfort Change at 12 Months (n=87, n=109)
|
-0.0 T-Scores of units on a scale
Standard Deviation 7.14
|
1.4 T-Scores of units on a scale
Standard Deviation 7.07
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Resilience Change at 4 Month LOCF (n=146, n=140)
|
1.9 T-Scores of units on a scale
Standard Deviation 10.52
|
1.3 T-Scores of units on a scale
Standard Deviation 11.25
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Resilience Change at 6 Month LOCF (n=147, n=143)
|
2.9 T-Scores of units on a scale
Standard Deviation 11.08
|
2.7 T-Scores of units on a scale
Standard Deviation 12.08
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Resilience 6 Month Baseline (n=108, n=122)
|
50.0 T-Scores of units on a scale
Standard Deviation 10.33
|
48.7 T-Scores of units on a scale
Standard Deviation 11.35
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Resilience Change at 12 Months (n=87, n=109)
|
-1.8 T-Scores of units on a scale
Standard Deviation 8.97
|
-1.0 T-Scores of units on a scale
Standard Deviation 9.14
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Risk Avoidance Baseline (n=158, n=155)
|
44.1 T-Scores of units on a scale
Standard Deviation 11.81
|
44.3 T-Scores of units on a scale
Standard Deviation 11.65
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Risk Avoidance Change: 4 Month LOCF (n=139, n=135)
|
6.2 T-Scores of units on a scale
Standard Deviation 11.17
|
7.6 T-Scores of units on a scale
Standard Deviation 10.02
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Risk Avoidance Change: 6 Month LOCF (n=145, n=142)
|
6.0 T-Scores of units on a scale
Standard Deviation 10.89
|
8.9 T-Scores of units on a scale
Standard Deviation 10.48
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Risk Avoidance 6 Month Baseline (n=108, n=118)
|
51.2 T-Scores of units on a scale
Standard Deviation 8.61
|
53.3 T-Scores of units on a scale
Standard Deviation 9.02
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Risk Avoidance Change at 12 Months (n=87, n=106)
|
-0.6 T-Scores of units on a scale
Standard Deviation 8.10
|
-0.4 T-Scores of units on a scale
Standard Deviation 7.30
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Satisfaction Baseline (n=159, n=155)
|
47.1 T-Scores of units on a scale
Standard Deviation 13.50
|
45.2 T-Scores of units on a scale
Standard Deviation 12.18
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Satisfaction Change at 4 Month LOCF (n=146, n=140)
|
0.3 T-Scores of units on a scale
Standard Deviation 10.40
|
4.1 T-Scores of units on a scale
Standard Deviation 12.23
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Satisfaction Change at 6 Month LOCF (n=147, n=143)
|
0.7 T-Scores of units on a scale
Standard Deviation 10.72
|
4.9 T-Scores of units on a scale
Standard Deviation 12.17
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Satisfaction 6 Month Baseline (n=108, n=121)
|
49.4 T-Scores of units on a scale
Standard Deviation 11.66
|
50.1 T-Scores of units on a scale
Standard Deviation 11.07
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
Satisfaction Change at 12 Months (n=87, n=109)
|
0.4 T-Scores of units on a scale
Standard Deviation 10.61
|
0.5 T-Scores of units on a scale
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 6 months, 12 monthsPopulation: Number of "adolescent" participants who received at least one dose of study drug and did not have a missing value. Last observation carried forward (LOCF). Change at 12 months is in the participants who continue in the optional extension period (atomoxetine n=27, OEST n=31). Their data at 6 months was taken as baseline for the 12 month change.
CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Outcome measures
| Measure |
Atomoxetine
n=39 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=43 Participants
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Achievement Change at 12 Months (n=17, n=24)
|
-1.8 T-Scores of units on a scale
Standard Deviation 5.46
|
-0.5 T-Scores of units on a scale
Standard Deviation 8.48
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Satisfaction Baseline (n=37, n=38)
|
49.7 T-Scores of units on a scale
Standard Deviation 8.68
|
49.6 T-Scores of units on a scale
Standard Deviation 11.62
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Satisfaction Change at 4 Month LOCF (n=31, n=34)
|
2.1 T-Scores of units on a scale
Standard Deviation 7.21
|
2.4 T-Scores of units on a scale
Standard Deviation 6.83
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Satisfaction Change at 6 Month LOCF (n=32, n=36)
|
2.8 T-Scores of units on a scale
Standard Deviation 7.62
|
6.3 T-Scores of units on a scale
Standard Deviation 8.51
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Satisfaction 6 Month Baseline (n=26, n=30)
|
51.2 T-Scores of units on a scale
Standard Deviation 10.55
|
55.4 T-Scores of units on a scale
Standard Deviation 7.56
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Satisfaction Change at 12 Months (n=17, n=25)
|
-2.6 T-Scores of units on a scale
Standard Deviation 4.79
|
-1.4 T-Scores of units on a scale
Standard Deviation 6.79
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Comfort Baseline (n=37, n=38)
|
53.0 T-Scores of units on a scale
Standard Deviation 9.11
|
51.6 T-Scores of units on a scale
Standard Deviation 9.00
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Comfort Change at 4 Month LOCF (n=31, n=33)
|
1.4 T-Scores of units on a scale
Standard Deviation 11.24
|
2.6 T-Scores of units on a scale
Standard Deviation 7.21
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Comfort Change at 6 Month LOCF (n=32, n=35)
|
1.3 T-Scores of units on a scale
Standard Deviation 11.87
|
4.7 T-Scores of units on a scale
Standard Deviation 7.27
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Comfort 6 Month Baseline (n=26, n=30)
|
55.1 T-Scores of units on a scale
Standard Deviation 7.81
|
55.8 T-Scores of units on a scale
Standard Deviation 6.36
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Comfort Change at 12 Months (n=17, n=25)
|
2.3 T-Scores of units on a scale
Standard Deviation 7.26
|
-0.2 T-Scores of units on a scale
Standard Deviation 5.06
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Risk Avoidance Baseline (n=37, n=37)
|
55.2 T-Scores of units on a scale
Standard Deviation 8.10
|
54.4 T-Scores of units on a scale
Standard Deviation 7.95
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Risk Avoidance Change: 4 Month LOCF (n=31, n=33)
|
1.3 T-Scores of units on a scale
Standard Deviation 6.35
|
2.0 T-Scores of units on a scale
Standard Deviation 3.56
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Risk Avoidance Change: 6 Month LOCF (n=32, n=35)
|
0.6 T-Scores of units on a scale
Standard Deviation 6.74
|
2.8 T-Scores of units on a scale
Standard Deviation 3.89
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Risk Avoidance 6 Month Baseline (n=26, n=30)
|
57.5 T-Scores of units on a scale
Standard Deviation 8.46
|
57.6 T-Scores of units on a scale
Standard Deviation 7.12
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Risk Avoidance Change at 12 Months (n=17, n=23)
|
-1.2 T-Scores of units on a scale
Standard Deviation 4.51
|
0.1 T-Scores of units on a scale
Standard Deviation 2.68
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Resilience Baseline (n=35, n=37)
|
45.0 T-Scores of units on a scale
Standard Deviation 9.33
|
45.4 T-Scores of units on a scale
Standard Deviation 7.33
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Resilience Change at 4 Month LOCF (n=29, n=33)
|
0.8 T-Scores of units on a scale
Standard Deviation 6.92
|
0.3 T-Scores of units on a scale
Standard Deviation 5.67
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Resilience Change at 6 Month LOCF (n=30, n=35)
|
-0.7 T-Scores of units on a scale
Standard Deviation 6.14
|
1.8 T-Scores of units on a scale
Standard Deviation 7.36
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Resilience 6 Month Baseline (n=26, n=30)
|
44.1 T-Scores of units on a scale
Standard Deviation 7.89
|
47.9 T-Scores of units on a scale
Standard Deviation 8.25
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Resilience Change at 12 Months (n=17, n=24)
|
-1.4 T-Scores of units on a scale
Standard Deviation 6.25
|
-1.7 T-Scores of units on a scale
Standard Deviation 7.53
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Achievement Baseline (n=37, n=37)
|
49.1 T-Scores of units on a scale
Standard Deviation 10.63
|
49.3 T-Scores of units on a scale
Standard Deviation 9.72
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Achievement Change at 4 Month LOCF (n=31, n=32)
|
4.9 T-Scores of units on a scale
Standard Deviation 11.62
|
1.5 T-Scores of units on a scale
Standard Deviation 8.33
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Achievement Change at 6 Month LOCF (n=32, n=35)
|
3.1 T-Scores of units on a scale
Standard Deviation 11.04
|
2.3 T-Scores of units on a scale
Standard Deviation 7.96
|
|
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
Achievement 6 Month Baseline (n=26, n=30)
|
53.7 T-Scores of units on a scale
Standard Deviation 9.89
|
52.2 T-Scores of units on a scale
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: All randomized participants who received at least one dose of study drug and had non-missing values.
Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.
Outcome measures
| Measure |
Atomoxetine
n=398 Participants
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Achievement Baseline
|
0.288 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Achievement Month 6
|
0.329 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Achievement Change to Month 6
|
0.167 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Comfort Baseline
|
0.306 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Comfort Month 6
|
0.373 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Comfort Change to Month 6
|
0.286 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Resilience Baseline
|
0.271 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Resilience Month 6
|
0.429 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Resilience Change to Month 6
|
0.113 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Risk Avoidance Baseline
|
0.429 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Risk Avoidance Month 6
|
0.450 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Risk Avoidance Change to Month 6
|
0.296 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Satisfaction Baseline
|
0.310 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Satisfaction Month 6
|
0.336 correlation coefficient
|
—
|
|
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
Satisfaction Change to Month 6
|
0.133 correlation coefficient
|
—
|
Adverse Events
Atomoxetine
Serious events: 2 serious events
Other events: 150 other events
Deaths: 0 deaths
OEST
Serious events: 2 serious events
Other events: 146 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atomoxetine
n=199 participants at risk
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 participants at risk
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Infections and infestations
Otitis media
|
0.50%
1/199 • Number of events 1 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
0.00%
0/199 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
0.50%
1/199 • Number of events 1 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
0.00%
0/199 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/199 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
0.50%
1/199 • Number of events 1 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Juvenile arthritis
|
0.00%
0/199 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
0.50%
1/199 • Number of events 1 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
Other adverse events
| Measure |
Atomoxetine
n=199 participants at risk
0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
|
OEST
n=199 participants at risk
Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
14.6%
29/199 • Number of events 40 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
11.1%
22/199 • Number of events 27 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.0%
18/199 • Number of events 21 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
6.5%
13/199 • Number of events 13 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
12.6%
25/199 • Number of events 25 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
7.0%
14/199 • Number of events 14 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
21/199 • Number of events 25 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
5.5%
11/199 • Number of events 11 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
11.6%
23/199 • Number of events 24 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
2.5%
5/199 • Number of events 5 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
General disorders
Irritability
|
1.5%
3/199 • Number of events 3 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
6.5%
13/199 • Number of events 13 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
11/199 • Number of events 13 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
6.0%
12/199 • Number of events 16 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
8.5%
17/199 • Number of events 17 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
4.0%
8/199 • Number of events 8 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
20.1%
40/199 • Number of events 40 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
25.1%
50/199 • Number of events 54 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.6%
25/199 • Number of events 25 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
14.1%
28/199 • Number of events 29 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
24.1%
48/199 • Number of events 57 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
22.1%
44/199 • Number of events 56 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
6.5%
13/199 • Number of events 13 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
1.0%
2/199 • Number of events 2 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Psychiatric disorders
Initial insomnia
|
1.5%
3/199 • Number of events 3 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
5.5%
11/199 • Number of events 11 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.0%
4/199 • Number of events 4 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
12.6%
25/199 • Number of events 25 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Psychiatric disorders
Tic
|
2.0%
4/199 • Number of events 4 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
5.0%
10/199 • Number of events 11 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
11/199 • Number of events 12 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
3.5%
7/199 • Number of events 7 • Baseline to 6 months (Study Period II)
Includes all patients in Study Period II who received at least one dose of study drug.
|
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