Trial Outcomes & Findings for Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany (NCT NCT00406354)
NCT ID: NCT00406354
Last Updated: 2010-02-26
Results Overview
The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
181 participants
Primary outcome timeframe
9 weeks
Results posted on
2010-02-26
Participant Flow
Participant milestones
| Measure |
Atomoxetine Fast Titration
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
matching placebo daily dose taken orally
|
|---|---|---|---|
|
All Randomized Patients
STARTED
|
60
|
61
|
60
|
|
All Randomized Patients
COMPLETED
|
60
|
61
|
59
|
|
All Randomized Patients
NOT COMPLETED
|
0
|
0
|
1
|
|
All Randomized and Treated Patients
STARTED
|
60
|
61
|
59
|
|
All Randomized and Treated Patients
COMPLETED
|
44
|
48
|
37
|
|
All Randomized and Treated Patients
NOT COMPLETED
|
16
|
13
|
22
|
Reasons for withdrawal
| Measure |
Atomoxetine Fast Titration
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
matching placebo daily dose taken orally
|
|---|---|---|---|
|
All Randomized Patients
Protocol Violation
|
0
|
0
|
1
|
|
All Randomized and Treated Patients
Lack of Efficacy
|
7
|
4
|
17
|
|
All Randomized and Treated Patients
Adverse Event
|
6
|
2
|
1
|
|
All Randomized and Treated Patients
Parent/Caregiver Decision
|
2
|
6
|
1
|
|
All Randomized and Treated Patients
Withdrawal by Subject
|
1
|
1
|
2
|
|
All Randomized and Treated Patients
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
Baseline characteristics by cohort
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
11.1 years
STANDARD_DEVIATION 2.88 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 3.39 • n=7 Participants
|
11.1 years
STANDARD_DEVIATION 2.77 • n=5 Participants
|
11.0 years
STANDARD_DEVIATION 3.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
60 participants
n=5 Participants
|
60 participants
n=7 Participants
|
58 participants
n=5 Participants
|
178 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
60 participants
n=5 Participants
|
61 participants
n=7 Participants
|
59 participants
n=5 Participants
|
180 participants
n=4 Participants
|
|
Prior Therapy: Attention-Deficit/Hyperactive Disorder (ADHD), Oppositional Defiant Disorder (ODD)
Previous treatment with stimulants
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
29 participants
n=5 Participants
|
80 participants
n=4 Participants
|
|
Prior Therapy: Attention-Deficit/Hyperactive Disorder (ADHD), Oppositional Defiant Disorder (ODD)
Previous psychotropic medication
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Prior Therapy: Attention-Deficit/Hyperactive Disorder (ADHD), Oppositional Defiant Disorder (ODD)
Previous non-drug treatment
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Prior Therapy: Attention-Deficit/Hyperactive Disorder (ADHD), Oppositional Defiant Disorder (ODD)
Previous psychotherapy
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Summary of ADHD Diagnosis
ADHD - combined type
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
47 participants
n=5 Participants
|
136 participants
n=4 Participants
|
|
Summary of ADHD Diagnosis
ADHD - predominantly inattentive type
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
8 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Summary of ADHD Diagnosis
ADHD - predominantly hyperactive-impulsive type
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Summary of ODD Diagnosis
Conduct disorder
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Summary of ODD Diagnosis
Oppositional defiant disorder
|
44 participants
n=5 Participants
|
45 participants
n=7 Participants
|
45 participants
n=5 Participants
|
134 participants
n=4 Participants
|
|
Summary of ODD Diagnosis
Disruptive behavior disorder not specified
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Summary of ODD Diagnosis
Adjustment disorder, emotion, conduct disturbance
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Clinical Global Impressions - Severity (CGI-S): ADHD Score
|
5.0 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 0.79 • n=7 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.77 • n=4 Participants
|
|
Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
|
4.9 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 0.73 • n=7 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.71 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.76 • n=4 Participants
|
|
Clinical Global Impressions - Severity (CGI-S): ODD Score
|
4.9 units on a scale
STANDARD_DEVIATION 0.92 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 0.83 • n=7 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 0.86 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 0.88 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
|
72.9 units on a scale
STANDARD_DEVIATION 18.58 • n=5 Participants
|
72.5 units on a scale
STANDARD_DEVIATION 17.28 • n=7 Participants
|
70.1 units on a scale
STANDARD_DEVIATION 15.92 • n=5 Participants
|
71.9 units on a scale
STANDARD_DEVIATION 17.22 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
|
58.7 units on a scale
STANDARD_DEVIATION 20.17 • n=5 Participants
|
57.6 units on a scale
STANDARD_DEVIATION 20.73 • n=7 Participants
|
52.3 units on a scale
STANDARD_DEVIATION 20.50 • n=5 Participants
|
56.2 units on a scale
STANDARD_DEVIATION 20.55 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
|
58.2 units on a scale
STANDARD_DEVIATION 21.56 • n=5 Participants
|
53.9 units on a scale
STANDARD_DEVIATION 21.23 • n=7 Participants
|
54.2 units on a scale
STANDARD_DEVIATION 23.34 • n=5 Participants
|
55.4 units on a scale
STANDARD_DEVIATION 22.02 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
|
79.8 units on a scale
STANDARD_DEVIATION 18.53 • n=5 Participants
|
75.9 units on a scale
STANDARD_DEVIATION 19.99 • n=7 Participants
|
81.5 units on a scale
STANDARD_DEVIATION 16.78 • n=5 Participants
|
79.0 units on a scale
STANDARD_DEVIATION 18.54 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
|
62.2 units on a scale
STANDARD_DEVIATION 16.74 • n=5 Participants
|
61.5 units on a scale
STANDARD_DEVIATION 20.62 • n=7 Participants
|
62.4 units on a scale
STANDARD_DEVIATION 15.06 • n=5 Participants
|
62.0 units on a scale
STANDARD_DEVIATION 17.50 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
|
55.4 units on a scale
STANDARD_DEVIATION 18.48 • n=5 Participants
|
52.0 units on a scale
STANDARD_DEVIATION 18.71 • n=7 Participants
|
50.4 units on a scale
STANDARD_DEVIATION 18.92 • n=5 Participants
|
52.6 units on a scale
STANDARD_DEVIATION 18.71 • n=4 Participants
|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
|
64.5 units on a scale
STANDARD_DEVIATION 12.43 • n=5 Participants
|
62.4 units on a scale
STANDARD_DEVIATION 12.92 • n=7 Participants
|
61.8 units on a scale
STANDARD_DEVIATION 13.02 • n=5 Participants
|
62.9 units on a scale
STANDARD_DEVIATION 12.78 • n=4 Participants
|
|
Impact on Family Scale (FaBel): Total Impact Score
|
53.3 units on a scale
STANDARD_DEVIATION 12.88 • n=5 Participants
|
54.1 units on a scale
STANDARD_DEVIATION 13.15 • n=7 Participants
|
53.9 units on a scale
STANDARD_DEVIATION 12.83 • n=5 Participants
|
53.8 units on a scale
STANDARD_DEVIATION 12.89 • n=4 Participants
|
|
Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
|
10.9 units on a scale
STANDARD_DEVIATION 2.03 • n=5 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 2.06 • n=7 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 2.27 • n=4 Participants
|
|
Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
|
21.3 units on a scale
STANDARD_DEVIATION 3.62 • n=5 Participants
|
22.1 units on a scale
STANDARD_DEVIATION 3.39 • n=7 Participants
|
20.5 units on a scale
STANDARD_DEVIATION 3.57 • n=5 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 3.56 • n=4 Participants
|
|
Parent-Rated Attention-Deficit Scale (FBB-HKS): Total Score, Severity
|
2.0 units on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.54 • n=7 Participants
|
1.9 units on a scale
STANDARD_DEVIATION 0.52 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.56 • n=4 Participants
|
|
Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
|
1.4 units on a scale
STANDARD_DEVIATION 0.53 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 0.49 • n=7 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 0.56 • n=5 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 0.52 • n=4 Participants
|
|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Subscale Score
|
17.7 units on a scale
STANDARD_DEVIATION 5.23 • n=5 Participants
|
18.3 units on a scale
STANDARD_DEVIATION 4.91 • n=7 Participants
|
17.5 units on a scale
STANDARD_DEVIATION 4.94 • n=5 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 5.01 • n=4 Participants
|
|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
|
19.9 units on a scale
STANDARD_DEVIATION 4.98 • n=5 Participants
|
19.7 units on a scale
STANDARD_DEVIATION 4.76 • n=7 Participants
|
18.9 units on a scale
STANDARD_DEVIATION 4.85 • n=5 Participants
|
19.5 units on a scale
STANDARD_DEVIATION 4.85 • n=4 Participants
|
|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ODD Score
|
15.5 units on a scale
STANDARD_DEVIATION 4.07 • n=5 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 3.82 • n=7 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 5.13 • n=5 Participants
|
15.5 units on a scale
STANDARD_DEVIATION 4.35 • n=4 Participants
|
|
Swanson, Nolan & Pelham Rating Scale-Revised (SNAP-IV): ADHD Combined Score
|
37.6 units on a scale
STANDARD_DEVIATION 9.70 • n=5 Participants
|
38.0 units on a scale
STANDARD_DEVIATION 8.91 • n=7 Participants
|
36.4 units on a scale
STANDARD_DEVIATION 9.31 • n=5 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 9.28 • n=4 Participants
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The SNAP-IV, a 26-item scale, includes 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD and 1 item for each of the 8 symptoms contained in the DSM-IV diagnosis of ODD. Each item is scored on a 0 to 3 scale (0=Not at All, 1=Just a Little, 2=Pretty Much, 3=Very Much). The SNAP-IV yields scores in three domains: Inattention (items 1-9: subscore range=0-27), Hyperact-ivity/Impulsivity (items 10-18: subscale range=0-27), and Oppositional (items 19-26: subscale range=0-24). SNAP-IV: ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score
|
8.6 units on a scale
Standard Error 0.7
|
9.0 units on a scale
Standard Error 0.7
|
12.0 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The SNAP-IV: ADHD Combined Subscale for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 54.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score
|
22.9 units on a scale
Standard Error 1.5
|
21.3 units on a scale
Standard Error 1.4
|
29.6 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score
|
11.1 units on a scale
Standard Error 0.7
|
10.0 units on a scale
Standard Error 0.7
|
14.1 units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The SNAP-IV: ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 27.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score
|
11.5 units on a scale
Standard Error 0.8
|
11.1 units on a scale
Standard Error 0.7
|
15.2 units on a scale
Standard Error 0.8
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
FBB-HKS ("Fremdbeurteilungsbogen fur Hyperkinetische Storungen"), the German, parent-rated scale for attention-deficit, is a 20-item rating scale which describes ADHD symptom criteria of DSM-IV and is grouped based upon the 3 ADHD domains: inattention (items 1-9); hyperactivity (items 10-16); impulsivity (items 17-20). Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ADHD overall (sum of ratings for items 1-20, divided by 20). Higher scores indicate higher severity of symptoms.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity
|
1.2 units on a scale
Standard Error 0.1
|
1.1 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
FBB-SSV ("Fremdbeurteilungsbogen fur Storungen des Sozialverhaltens"), the German, parent-rated oppositional defiant/conduct disorders scale, covers 23 criteria for ODD and 25 for conduct disorder (CD) in four sections. Parents rated symptom severity of each item during the last 7 days on a 0 to 3 scale (0=not at all to 3=very much). The total score was calculated for ODD/CD overall (sum of ratings for items 1-17, divided by 17). Higher scores indicate higher severity of symptoms.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity
|
0.8 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.1
|
1.0 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Intensity during the last 7 days is rated on a 10-point scale (0=no problems to 9=most severe problems) with the lowest possible score of 0 and the highest possible of 27.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score
|
10.8 units on a scale
Standard Error 1.1
|
11.9 units on a scale
Standard Error 1.0
|
14.9 units on a scale
Standard Error 1.1
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
ITB-Inv assesses frequency and intensity of individually-defined target behaviors. The investigator defines 3 individual behavior problems based on interviews and additional information. Those most impairing for the child or stressful for the parents will be chosen as target behavior. Frequency of each target behavior during the last 7 days is rated on a 6-point scale (0=never to 5=always) with 0 as lowest possible score and 15 the highest possible score.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score
|
6.0 units on a scale
Standard Error 0.6
|
6.6 units on a scale
Standard Error 0.6
|
8.1 units on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
Family burden is assessed by the FaBel questionnaire (German version of the Impact on Family Scale). Questionnaire is answered by participant's caregiver and contains 33 Likert-scaled items to assess general negative impact (of a disability, disorder, disease) on parents, description of social relationships, concern for siblings, financial impact, problems in coping as well as a total score. Each item is rated on a 4-point scale (1=fully applies, 4=applies not at all). Total scores range from 24-96. Higher scores correspond to higher family burden.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Impact on Family Scale (FaBel), Total Impact Score
|
54.2 units on a scale
Standard Error 1.4
|
50.6 units on a scale
Standard Error 1.4
|
53.8 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The physician-rated CGI-S ADHD measures the participant's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Clinical Global Impressions - Severity (CGI-S): ADHD Score
|
3.5 units on a scale
Standard Error 0.1
|
3.6 units on a scale
Standard Error 0.1
|
4.3 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The physician-rated CGI-S ODD measures the participant's overall severity of ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Clinical Global Impressions - Severity (CGI-S): ODD Score
|
3.6 units on a scale
Standard Error 0.2
|
3.5 units on a scale
Standard Error 0.1
|
4.3 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
The physician-rated CGI-S Combined ADHD and ODD measures the participant's overall severity of both ADHD and ODD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients) during the last 7 days.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores
|
3.7 units on a scale
Standard Error 0.1
|
3.5 units on a scale
Standard Error 0.1
|
4.4 units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score in the Total QOL score is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher score indicates better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score
|
66.0 units on a scale
Standard Error 1.8
|
65.6 units on a scale
Standard Error 1.8
|
60.7 units on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Physical Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score
|
69.1 units on a scale
Standard Error 2.7
|
71.9 units on a scale
Standard Error 2.6
|
78.1 units on a scale
Standard Error 2.6
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time).The lowest possible score for the Emotional Well-Being subscale is 0; highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score
|
71.8 units on a scale
Standard Error 2.3
|
73.0 units on a scale
Standard Error 2.3
|
66.9 units on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Self Esteem subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score
|
60.1 units on a scale
Standard Error 2.5
|
57.3 units on a scale
Standard Error 2.4
|
48.0 units on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1=never; 5=all the time). The lowest possible score on the Family subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score
|
63.7 units on a scale
Standard Error 2.8
|
61.9 units on a scale
Standard Error 2.7
|
54.7 units on a scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the Friends subscale is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score
|
67.1 units on a scale
Standard Error 2.8
|
61.3 units on a scale
Standard Error 2.8
|
56.2 units on a scale
Standard Error 2.8
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
KINDL-R ("Revidierter KINDer Lebensqualitatsfragebogen, revised version"), a validated German quality of life (QOL) questionnaire, provides parents' views on their child's emotional QOL. It consists of 24 items covering 6 QOL related dimensions (subscales) and 7 additional items assessing chronic illness. Each item is rated on a 5-point scale (1= never; 5= all the time). The lowest possible score on the School subscore is 0; the highest possible score is 100. Scores were normalized between 0 and 100, irrespective of the number of items per subscore. Higher scores indicate better QOL.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score
|
63.4 units on a scale
Standard Error 2.8
|
67.4 units on a scale
Standard Error 2.8
|
60.5 units on a scale
Standard Error 2.8
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All participants randomized and receiving at least one dose of study drug.
Originally, time to treatment discontinuation was analyzed, deeming participants 'censored' if they reached the end of the observation period, were lost to followup, or withdrew informed consent. Because the median was not reached, the number of participants who discontinued (i.e., those who were not censored) is reported here.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Number of Participants Discontinuing Treatment
Age <12 Years
|
4 participants
|
8 participants
|
15 participants
|
|
Number of Participants Discontinuing Treatment
Age >=12 Years
|
2 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: All randomized participants who received at least one dose of study drug.
Number of participants who experienced pre-specified categories of clinically relevant adverse events during the initial three-weeks of study treatment. NOTE: this is a subset of the overall adverse events which are reported by participant and event.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Nausea or related symptoms
|
21 participants
|
18 participants
|
5 participants
|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Fatigue or related symptoms
|
19 participants
|
14 participants
|
6 participants
|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Gastrointestinal complaints
|
12 participants
|
8 participants
|
2 participants
|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment
Sleep disturbances
|
2 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: All randomized participants who received at least one dose of study drug.
Number of participants who experienced pre-specified categories of clinically relevant adverse events during the nine-week study treatment period. NOTE: this is a subset of the overall adverse events which are reported by participant and event.
Outcome measures
| Measure |
Atomoxetine Fast Titration
n=60 Participants
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 Participants
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 Participants
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Nausea or related symptoms
|
25 participants
|
21 participants
|
6 participants
|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Fatigue or related symptoms
|
20 participants
|
14 participants
|
6 participants
|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Gastrointestinal complaints
|
14 participants
|
12 participants
|
3 participants
|
|
Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period
Sleep disturbances
|
4 participants
|
3 participants
|
2 participants
|
Adverse Events
Atomoxetine Fast Titration
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Atomoxetine Slow Titration
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atomoxetine Fast Titration
n=60 participants at risk
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 participants at risk
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 participants at risk
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/60 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/61 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/60 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.6%
1/61 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
General disorders
Chest pain
|
0.00%
0/60 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.6%
1/61 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.7%
1/59 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
Other adverse events
| Measure |
Atomoxetine Fast Titration
n=60 participants at risk
0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
|
Atomoxetine Slow Titration
n=61 participants at risk
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
|
Placebo
n=59 participants at risk
matching placebo daily dose taken orally
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
3/60 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/61 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Eye disorders
Mydriasis
|
11.7%
7/60 • Number of events 7 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
8.2%
5/61 • Number of events 5 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
5/60 • Number of events 5 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
9.8%
6/61 • Number of events 7 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 4 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.3%
8/60 • Number of events 9 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
11.5%
7/61 • Number of events 7 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/60 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
6.6%
4/61 • Number of events 4 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Gastrointestinal disorders
Nausea
|
21.7%
13/60 • Number of events 15 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
19.7%
12/61 • Number of events 12 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
9/60 • Number of events 11 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
18.0%
11/61 • Number of events 12 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
General disorders
Fatigue
|
35.0%
21/60 • Number of events 22 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
21.3%
13/61 • Number of events 14 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
10.2%
6/59 • Number of events 6 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
General disorders
Pyrexia
|
8.3%
5/60 • Number of events 6 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
3.3%
2/61 • Number of events 2 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
6/60 • Number of events 6 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
3.3%
2/61 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Infections and infestations
Rhinitis
|
5.0%
3/60 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.6%
1/61 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.7%
1/59 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
9/60 • Number of events 9 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
11.5%
7/61 • Number of events 7 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.7%
1/59 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
3/60 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
6.6%
4/61 • Number of events 4 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Nervous system disorders
Dizziness
|
3.3%
2/60 • Number of events 2 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.6%
1/61 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Nervous system disorders
Headache
|
25.0%
15/60 • Number of events 24 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
14.8%
9/61 • Number of events 10 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
15.3%
9/59 • Number of events 10 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Psychiatric disorders
Aggression
|
3.3%
2/60 • Number of events 2 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.6%
1/61 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
6.8%
4/59 • Number of events 4 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Psychiatric disorders
Sleep disorder
|
5.0%
3/60 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.6%
1/61 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
0.00%
0/59 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.7%
7/60 • Number of events 8 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
8.2%
5/61 • Number of events 5 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
5.1%
3/59 • Number of events 3 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.3%
5/60 • Number of events 6 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
3.3%
2/61 • Number of events 2 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
1.7%
1/59 • Number of events 1 • Adverse events reported by participant and event over the complete nine-week study treatment period (NOTE: includes events within clinically relevant categories reported in Outcome Measures #21 [initial three weeks] and #22 [nine-week treatment period]).
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60