Trial Outcomes & Findings for A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine (NCT NCT00471354)
NCT ID: NCT00471354
Last Updated: 2010-01-12
Results Overview
Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
COMPLETED
PHASE4
228 participants
Baseline, 24 weeks
2010-01-12
Participant Flow
Participant milestones
| Measure |
Atomoxetine
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Overall Study
STARTED
|
228
|
|
Overall Study
COMPLETED
|
176
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Atomoxetine
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Overall Study
Protocol Entry Criteria Not Met
|
1
|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Protocol Violation
|
12
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Sponsor Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Patient/Caregiver Decision
|
12
|
Baseline Characteristics
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=228 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Age Continuous
|
9.6 years
STANDARD_DEVIATION 0.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
194 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
76 participants
n=5 Participants
|
|
Region of Enrollment
China
|
82 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
70 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Subtypes
Hyperactive
|
5 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Subtypes
Combined
|
141 participants
n=5 Participants
|
|
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Subtypes
Inattentive
|
82 participants
n=5 Participants
|
|
Race/Ethnicity
East Asian
|
228 participants
n=5 Participants
|
|
Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score
|
35.3 units on a scale
STANDARD_DEVIATION 7.09 • n=5 Participants
|
|
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S)
|
5.0 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
|
Conners' Parent Rating Scale-Revised:Short Form - ADHD Index Subscale
|
24.5 units on a scale
STANDARD_DEVIATION 5.90 • n=5 Participants
|
|
Height
|
136.4 centimeters (cm)
STANDARD_DEVIATION 8.25 • n=5 Participants
|
|
School Grade Average (SGA) Language Score
|
73.8 units on a scale
STANDARD_DEVIATION 18.35 • n=5 Participants
|
|
School Grade Average (SGA) Math Score
|
72.7 units on a scale
STANDARD_DEVIATION 19.89 • n=5 Participants
|
|
School Grade Average (SGA) Total Score
|
73.9 units on a scale
STANDARD_DEVIATION 15.82 • n=5 Participants
|
|
School Grade Score (SGA) Science Score
|
75.0 units on a scale
STANDARD_DEVIATION 17.04 • n=5 Participants
|
|
Weight
|
33.3 kilograms (kg)
STANDARD_DEVIATION 8.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).
Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
Outcome measures
| Measure |
Atomoxetine
n=164 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA)
|
-0.083 Spearman Correlation Coefficient
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables, regardless of them having or not having received any ordinal grades (for the SGA).
Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
Outcome measures
| Measure |
Atomoxetine
n=164 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
Correlation with Science Scores
|
-0.058 Spearman Correlation Coefficient
|
|
Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
Correlation with Language Scores
|
-0.086 Spearman Correlation Coefficient
|
|
Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes
Correlation with Math Scores
|
-0.126 Spearman Correlation Coefficient
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.
Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools.
Outcome measures
| Measure |
Atomoxetine
n=177 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
Change from Baseline in Language Scores
|
3.9 units on a scale
Standard Deviation 13.35
|
|
Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
Change from Baseline in Math Scores
|
4.1 units on a scale
Standard Deviation 16.58
|
|
Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
Change from Baseline in Science Scores
|
6.1 units on a scale
Standard Deviation 14.98
|
|
Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores
Change from Baseline in Total Scores
|
4.7 units on a scale
Standard Deviation 10.68
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.
Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Outcome measures
| Measure |
Atomoxetine
n=205 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score
|
-18.8 units on a scale
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.
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=228 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S)
|
-2.1 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.
Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).
Outcome measures
| Measure |
Atomoxetine
n=228 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint
|
2.3 units on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: All patients with baseline and at least one non-missing post-baseline score for each of the variables. Last observation carried forward.
A 27-item rating scale (0 \[not at all/never\] to 3 \[very much true/very often\]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD.
Outcome measures
| Measure |
Atomoxetine
n=204 Participants
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score
|
-9.8 units on a scale
Standard Deviation 7.94
|
Adverse Events
Atomoxetine
Serious adverse events
| Measure |
Atomoxetine
n=228 participants at risk
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Endocrine disorders
Hyperthyroidism
|
0.44%
1/228 • Number of events 1 • Adverse events were collected during the 24 week overall study period.
|
Other adverse events
| Measure |
Atomoxetine
n=228 participants at risk
0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
15/228 • Number of events 16 • Adverse events were collected during the 24 week overall study period.
|
|
Gastrointestinal disorders
Nausea
|
21.5%
49/228 • Number of events 57 • Adverse events were collected during the 24 week overall study period.
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
26/228 • Number of events 32 • Adverse events were collected during the 24 week overall study period.
|
|
General disorders
Fatigue
|
11.0%
25/228 • Number of events 28 • Adverse events were collected during the 24 week overall study period.
|
|
General disorders
Irritability
|
8.8%
20/228 • Number of events 24 • Adverse events were collected during the 24 week overall study period.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
15/228 • Number of events 15 • Adverse events were collected during the 24 week overall study period.
|
|
Investigations
Weight decreased
|
7.0%
16/228 • Number of events 19 • Adverse events were collected during the 24 week overall study period.
|
|
Metabolism and nutrition disorders
Anorexia
|
24.1%
55/228 • Number of events 61 • Adverse events were collected during the 24 week overall study period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.5%
74/228 • Number of events 91 • Adverse events were collected during the 24 week overall study period.
|
|
Nervous system disorders
Dizziness
|
13.6%
31/228 • Number of events 36 • Adverse events were collected during the 24 week overall study period.
|
|
Nervous system disorders
Headache
|
12.7%
29/228 • Number of events 33 • Adverse events were collected during the 24 week overall study period.
|
|
Nervous system disorders
Somnolence
|
20.2%
46/228 • Number of events 54 • Adverse events were collected during the 24 week overall study period.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60