Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.
Interventions
DRUGAtomoxetine
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
DRUGOther standard therapy for ADHD
Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * 6 to 16 years old * Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL) * Pharmacological naïve * Normal intelligence as assessed by investigator * Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain | Baseline, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline, 4 months, 6 months, 12 months | 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. |
| Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) | Baseline, 4 months, 6 months, 12 months | 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). |
| 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) | Baseline, 4 months, 6 months, 12 months | 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. |
| Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | Baseline, 4 months, 12 months | 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. |
| Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years) | Baseline, 4 months, 6 months, 12 months | 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. |
| Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years) | Baseline, 4 months, 6 months, 12 months | 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. |
| Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores | Baseline, 6 months | 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. |
| 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, 4 months, 6 months, 12 months | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). |
Countries
Belgium, France, Ireland, Italy, Mexico, Norway, Spain, Turkey (Türkiye), United Kingdom
Participant flow
Pre-assignment details
Study consisted of a 1 week screening (Period I); 6 months open-label (Period II); Optional additional 6 month open-label extension (Period III).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 199 |
| OEST Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension | 199 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period II (6 Month Open-Label) | Adverse Event | 7 | 3 |
| Period II (6 Month Open-Label) | Lack of Efficacy | 11 | 1 |
| Period II (6 Month Open-Label) | Lost to Follow-up | 0 | 4 |
| Period II (6 Month Open-Label) | Parent/Guardian Decision | 9 | 10 |
| Period II (6 Month Open-Label) | Physician Decision | 4 | 1 |
| Period II (6 Month Open-Label) | Protocol Violation | 10 | 7 |
| Period II (6 Month Open-Label) | Withdrawal by Subject | 1 | 3 |
| Period III (Optional 6 Month Extension) | Adverse Event | 2 | 2 |
| Period III (Optional 6 Month Extension) | Lack of Efficacy | 4 | 0 |
| Period III (Optional 6 Month Extension) | Lost to Follow-up | 2 | 2 |
| Period III (Optional 6 Month Extension) | Parent/Guardian Decision | 11 | 8 |
| Period III (Optional 6 Month Extension) | Physician Decision | 1 | 1 |
| Period III (Optional 6 Month Extension) | Protocol Violation | 6 | 1 |
| Period III (Optional 6 Month Extension) | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | OEST | Atomoxetine | Total |
|---|---|---|---|
| Age at Onset of Attention-Deficit/Hyperactivity Disorder (ADHD) | 4.2 years STANDARD_DEVIATION 1.91 | 4.3 years STANDARD_DEVIATION 1.88 | 4.2 years STANDARD_DEVIATION 1.89 |
| Age Continuous | 9.4 years STANDARD_DEVIATION 2.64 | 9.2 years STANDARD_DEVIATION 2.57 | 9.3 years STANDARD_DEVIATION 2.6 |
| Height | 140.1 centimeters STANDARD_DEVIATION 15.71 | 138.8 centimeters STANDARD_DEVIATION 14.59 | 139.4 centimeters STANDARD_DEVIATION 15.16 |
| Kiddie Schedule for Affective Disorders - Affective Disorder 0 Affective Disorders | 189 participants | 189 participants | 378 participants |
| Kiddie Schedule for Affective Disorders - Affective Disorder 1 Affective Disorder | 1 participants | 2 participants | 3 participants |
| Kiddie Schedule for Affective Disorders - Affective Disorder Missing Information | 9 participants | 8 participants | 17 participants |
| Kiddie Schedule for Affective Disorders - Anxiety Disorder 0 Anxiety Disorders | 173 participants | 176 participants | 349 participants |
| Kiddie Schedule for Affective Disorders - Anxiety Disorder 1 Anxiety Disorder | 18 participants | 11 participants | 29 participants |
| Kiddie Schedule for Affective Disorders - Anxiety Disorder 2 Anxiety Disorders | 6 participants | 4 participants | 10 participants |
| Kiddie Schedule for Affective Disorders - Anxiety Disorder 3 Anxiety Disorders | 0 participants | 2 participants | 2 participants |
| Kiddie Schedule for Affective Disorders - Anxiety Disorder 4 Anxiety Disorders | 0 participants | 1 participants | 1 participants |
| Kiddie Schedule for Affective Disorders - Anxiety Disorder Missing Information | 2 participants | 5 participants | 7 participants |
| Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes Combined ADHD Subtype | 156 participants | 156 participants | 312 participants |
| Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes Hyperactive/Impulsive ADHD Subtype | 7 participants | 4 participants | 11 participants |
| Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes Inattentive ADHD Subtype | 36 participants | 39 participants | 75 participants |
| Kiddie Schedule for Affective Disorders - Conduct Disorder No (never had the disorder) | 187 participants | 184 participants | 371 participants |
| Kiddie Schedule for Affective Disorders - Conduct Disorder Yes, but not present (had disorder in the past) | 2 participants | 2 participants | 4 participants |
| Kiddie Schedule for Affective Disorders - Conduct Disorder Yes (currently have the disorder) | 10 participants | 13 participants | 23 participants |
| Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder No (never had the disorder) | 122 participants | 118 participants | 240 participants |
| Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder Yes, but not present (had disorder in the past) | 4 participants | 2 participants | 6 participants |
| Kiddie Schedule for Affective Disorders - Oppositional Defiant Disorder Yes (currently have the disorder) | 73 participants | 79 participants | 152 participants |
| Kiddie Schedule for Affective Disorders - Tic Disorder 0 Tic Disorders | 178 participants | 176 participants | 354 participants |
| Kiddie Schedule for Affective Disorders - Tic Disorder 1 Tic Disorder | 14 participants | 13 participants | 27 participants |
| Kiddie Schedule for Affective Disorders - Tic Disorder 2 Tic Disorders | 2 participants | 2 participants | 4 participants |
| Kiddie Schedule for Affective Disorders - Tic Disorder 3 Tic Disorders | 3 participants | 3 participants | 6 participants |
| Kiddie Schedule for Affective Disorders - Tic Disorder Missing Information | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized African | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Caucasian | 181 participants | 180 participants | 361 participants |
| Race/Ethnicity, Customized East Asian | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic | 15 participants | 17 participants | 32 participants |
| Region of Enrollment Belgium | 23 participants | 23 participants | 46 participants |
| Region of Enrollment France | 32 participants | 32 participants | 64 participants |
| Region of Enrollment Ireland | 2 participants | 3 participants | 5 participants |
| Region of Enrollment Italy | 20 participants | 20 participants | 40 participants |
| Region of Enrollment Mexico | 12 participants | 11 participants | 23 participants |
| Region of Enrollment Norway | 10 participants | 10 participants | 20 participants |
| Region of Enrollment Spain | 58 participants | 61 participants | 119 participants |
| Region of Enrollment Turkey | 24 participants | 23 participants | 47 participants |
| Region of Enrollment United Kingdom | 18 participants | 16 participants | 34 participants |
| Sex: Female, Male Female | 41 Participants | 41 Participants | 82 Participants |
| Sex: Female, Male Male | 158 Participants | 158 Participants | 316 Participants |
| Time Since Onset of ADHD | 5.2 years STANDARD_DEVIATION 2.97 | 5.0 years STANDARD_DEVIATION 2.65 | 5.1 years STANDARD_DEVIATION 2.81 |
| Weight | 37.6 kilograms (kg) STANDARD_DEVIATION 13.35 | 37.5 kilograms (kg) STANDARD_DEVIATION 14.3 | 37.5 kilograms (kg) STANDARD_DEVIATION 13.82 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 150 / 199 | 146 / 199 |
| serious Total, serious adverse events | 2 / 199 | 2 / 199 |
Outcome results
Primary
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
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.
Time frame: Baseline, 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | 28.3 T-Scores of units on a scale | Standard Deviation 12.28 |
| OEST | 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) | 12.4 T-Scores of units on a scale | Standard Deviation 11.37 |
| OEST | 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) | 11.7 T-Scores of units on a scale | Standard Deviation 11.24 |
p-value: <0.00195% CI: [-6.47, -2.25]Mixed Models Analysis
p-value: <0.00195% CI: [-6.56, -2.63]ANCOVA
Secondary
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)
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.
Time frame: Baseline, 4 months, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 6.51 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | -1.63 units on a scale | Standard Deviation 4.644 |
| OEST | 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) | 40.35 units on a scale | Standard Deviation 8.818 |
| OEST | 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) | -20.1 units on a scale | Standard Deviation 11.562 |
| OEST | 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) | -20.3 units on a scale | Standard Deviation 11.397 |
| OEST | 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) | 18.62 units on a scale | Standard Deviation 10.255 |
| OEST | 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) | -2.71 units on a scale | Standard Deviation 8.998 |
| OEST | 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) | 21.55 units on a scale | Standard Deviation 4.373 |
| OEST | 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) | -11.1 units on a scale | Standard Deviation 6.15 |
| OEST | 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) | -11.2 units on a scale | Standard Deviation 6.339 |
| OEST | 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) | 9.51 units on a scale | Standard Deviation 5.51 |
| OEST | 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) | -1.13 units on a scale | Standard Deviation 5.273 |
| OEST | 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) | 18.80 units on a scale | Standard Deviation 6.252 |
| OEST | 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) | -8.97 units on a scale | Standard Deviation 6.572 |
| OEST | 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) | -9.13 units on a scale | Standard Deviation 6.255 |
| OEST | 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) | 9.11 units on a scale | Standard Deviation 5.77 |
p-value: 0.03495% CI: [0.173, 4.44]ANCOVA
p-value: 0.00595% CI: [0.942, 5.202]ANCOVA
p-value: 0.00495% CI: [0.544, 2.899]ANCOVA
p-value: <0.00195% CI: [1.086, 3.453]ANCOVA
p-value: 0.29895% CI: [-0.515, 1.676]ANCOVA
p-value: 0.11995% CI: [-0.225, 1.956]ANCOVA
Secondary
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time frame: Baseline, 4 months, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | -0.57 units on a scale | Standard Deviation 0.953 |
| OEST | 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) | 5.45 units on a scale | Standard Deviation 0.903 |
| OEST | 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) | -1.94 units on a scale | Standard Deviation 1.228 |
| OEST | 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) | -2.06 units on a scale | Standard Deviation 1.323 |
| OEST | 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) | 3.17 units on a scale | Standard Deviation 1.229 |
p-value: 0.36695% CI: [-0.122, 0.329]ANCOVA
p-value: 0.16595% CI: [-0.07, 0.407]ANCOVA
Secondary
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
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.
Time frame: Baseline, 4 months, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 8.1 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | -1.7 T-Scores of units on a scale | Standard Deviation 7.53 |
| OEST | 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) | 49.3 T-Scores of units on a scale | Standard Deviation 9.72 |
| OEST | 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) | 1.5 T-Scores of units on a scale | Standard Deviation 8.33 |
| OEST | 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) | 2.3 T-Scores of units on a scale | Standard Deviation 7.96 |
| OEST | 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) | 52.2 T-Scores of units on a scale | Standard Deviation 10.91 |
| OEST | 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) | -0.5 T-Scores of units on a scale | Standard Deviation 8.48 |
| OEST | 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) | 49.6 T-Scores of units on a scale | Standard Deviation 11.62 |
| OEST | 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) | 2.4 T-Scores of units on a scale | Standard Deviation 6.83 |
| OEST | 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) | 6.3 T-Scores of units on a scale | Standard Deviation 8.51 |
| OEST | 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) | 55.4 T-Scores of units on a scale | Standard Deviation 7.56 |
| OEST | 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) | -1.4 T-Scores of units on a scale | Standard Deviation 6.79 |
| OEST | 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) | 51.6 T-Scores of units on a scale | Standard Deviation 9 |
| OEST | 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) | 2.6 T-Scores of units on a scale | Standard Deviation 7.21 |
| OEST | 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) | 4.7 T-Scores of units on a scale | Standard Deviation 7.27 |
| OEST | 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) | 55.8 T-Scores of units on a scale | Standard Deviation 6.36 |
| OEST | 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) | -0.2 T-Scores of units on a scale | Standard Deviation 5.06 |
| OEST | 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) | 54.4 T-Scores of units on a scale | Standard Deviation 7.95 |
| OEST | 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) | 2.0 T-Scores of units on a scale | Standard Deviation 3.56 |
| OEST | 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) | 2.8 T-Scores of units on a scale | Standard Deviation 3.89 |
| OEST | 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) | 57.6 T-Scores of units on a scale | Standard Deviation 7.12 |
| OEST | 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) | 0.1 T-Scores of units on a scale | Standard Deviation 2.68 |
| OEST | 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) | 45.4 T-Scores of units on a scale | Standard Deviation 7.33 |
| OEST | 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) | 0.3 T-Scores of units on a scale | Standard Deviation 5.67 |
| OEST | 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) | 1.8 T-Scores of units on a scale | Standard Deviation 7.36 |
| OEST | 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) | 47.9 T-Scores of units on a scale | Standard Deviation 8.25 |
p-value: 0.26395% CI: [-1.83, 6.6]ANCOVA
p-value: 0.84895% CI: [-3.6, 4.36]ANCOVA
p-value: 0.89595% CI: [-3.01, 2.64]ANCOVA
p-value: 0.03895% CI: [-6.22, -0.19]ANCOVA
p-value: 0.85495% CI: [-3.59, 2.98]ANCOVA
p-value: 0.16195% CI: [-5.45, 0.92]ANCOVA
p-value: 0.5495% CI: [-2.98, 1.58]ANCOVA
p-value: 0.10695% CI: [-4.4, 0.44]ANCOVA
p-value: 0.83395% CI: [-2.49, 3.08]ANCOVA
p-value: 0.1195% CI: [-5.21, 0.54]ANCOVA
Secondary
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
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.
Time frame: Baseline, 4 months, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 8.1 |
| Atomoxetine | 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 |
| Atomoxetine | 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 13.5 |
| Atomoxetine | 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 |
| Atomoxetine | 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 10.4 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | 0.5 T-Scores of units on a scale | Standard Deviation 8.91 |
| OEST | 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) | 7.0 T-Scores of units on a scale | Standard Deviation 12.38 |
| OEST | 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) | 36.5 T-Scores of units on a scale | Standard Deviation 13.03 |
| OEST | 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) | 8.8 T-Scores of units on a scale | Standard Deviation 12.19 |
| OEST | 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) | 46.3 T-Scores of units on a scale | Standard Deviation 12.5 |
| OEST | 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) | -0.1 T-Scores of units on a scale | Standard Deviation 11.19 |
| OEST | 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) | 48.2 T-Scores of units on a scale | Standard Deviation 9.2 |
| OEST | 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) | 5.2 T-Scores of units on a scale | Standard Deviation 8.74 |
| OEST | 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) | 6.3 T-Scores of units on a scale | Standard Deviation 9.14 |
| OEST | 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) | 54.0 T-Scores of units on a scale | Standard Deviation 8.15 |
| OEST | 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) | 1.4 T-Scores of units on a scale | Standard Deviation 7.07 |
| OEST | 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) | 46.0 T-Scores of units on a scale | Standard Deviation 11.12 |
| OEST | 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) | 1.3 T-Scores of units on a scale | Standard Deviation 11.25 |
| OEST | 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) | 2.7 T-Scores of units on a scale | Standard Deviation 12.08 |
| OEST | 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) | 48.7 T-Scores of units on a scale | Standard Deviation 11.35 |
| OEST | 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) | -1.0 T-Scores of units on a scale | Standard Deviation 9.14 |
| OEST | 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) | 44.3 T-Scores of units on a scale | Standard Deviation 11.65 |
| OEST | 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) | 7.6 T-Scores of units on a scale | Standard Deviation 10.02 |
| OEST | 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) | 8.9 T-Scores of units on a scale | Standard Deviation 10.48 |
| OEST | 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) | 53.3 T-Scores of units on a scale | Standard Deviation 9.02 |
| OEST | 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) | -0.4 T-Scores of units on a scale | Standard Deviation 7.3 |
| OEST | 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) | 45.2 T-Scores of units on a scale | Standard Deviation 12.18 |
| OEST | 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) | 4.1 T-Scores of units on a scale | Standard Deviation 12.23 |
| OEST | 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) | 4.9 T-Scores of units on a scale | Standard Deviation 12.17 |
| OEST | 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) | 50.1 T-Scores of units on a scale | Standard Deviation 11.07 |
p-value: 0.05495% CI: [-4.74, 0.04]ANCOVA
p-value: 0.00395% CI: [-6.16, -1.26]ANCOVA
p-value: 0.03395% CI: [-3.33, -0.14]ANCOVA
p-value: 0.00395% CI: [-4.12, -0.88]ANCOVA
p-value: 0.62395% CI: [-1.5, 2.5]ANCOVA
p-value: 0.8895% CI: [-1.96, 2.29]ANCOVA
p-value: 0.14995% CI: [-3.31, 0.5]ANCOVA
p-value: 0.00395% CI: [-4.58, -0.98]ANCOVA
p-value: 0.01595% CI: [-4.71, -0.52]ANCOVA
p-value: 0.00495% CI: [-5.26, -0.98]ANCOVA
Secondary
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)
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.
Time frame: Baseline, 4 months, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 10.6 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 12.9 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | 7.2 T-Scores of units on a scale | Standard Deviation 15.94 |
| OEST | 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) | 43.0 T-Scores of units on a scale | Standard Deviation 11.27 |
| OEST | 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) | 31.2 T-Scores of units on a scale | Standard Deviation 20.14 |
| OEST | 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) | 5.2 T-Scores of units on a scale | Standard Deviation 11.22 |
| OEST | 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) | 32.8 T-Scores of units on a scale | Standard Deviation 16.29 |
| OEST | 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) | 4.7 T-Scores of units on a scale | Standard Deviation 11.64 |
| OEST | 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) | 9.3 T-Scores of units on a scale | Standard Deviation 14.2 |
| OEST | 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) | 47.7 T-Scores of units on a scale | Standard Deviation 9.78 |
| OEST | 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) | 1.0 T-Scores of units on a scale | Standard Deviation 10.96 |
| OEST | 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) | -0.5 T-Scores of units on a scale | Standard Deviation 10.28 |
| OEST | 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) | 9.6 T-Scores of units on a scale | Standard Deviation 15.16 |
| OEST | 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) | 38.9 T-Scores of units on a scale | Standard Deviation 12.63 |
| OEST | 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) | 6.9 T-Scores of units on a scale | Standard Deviation 16.18 |
| OEST | 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) | 3.8 T-Scores of units on a scale | Standard Deviation 13.38 |
| OEST | 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) | 41.1 T-Scores of units on a scale | Standard Deviation 16.23 |
| OEST | 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) | 5.5 T-Scores of units on a scale | Standard Deviation 12.99 |
| OEST | 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) | 40.7 T-Scores of units on a scale | Standard Deviation 16.17 |
| OEST | 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) | 45.3 T-Scores of units on a scale | Standard Deviation 14.08 |
| OEST | 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) | 2.2 T-Scores of units on a scale | Standard Deviation 10.25 |
| OEST | 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) | -0.3 T-Scores of units on a scale | Standard Deviation 11.98 |
p-value: 0.00295% CI: [-4.92, -1.15]ANCOVA
p-value: 0.03195% CI: [-4.01, -0.2]ANCOVA
p-value: 0.62995% CI: [-1.68, 2.77]ANCOVA
p-value: 0.42195% CI: [-3.3, 1.38]ANCOVA
p-value: 0.38895% CI: [-3.44, 1.34]ANCOVA
p-value: 0.05995% CI: [-4.66, 0.09]ANCOVA
p-value: 0.00695% CI: [-6.09, -1.04]ANCOVA
p-value: 0.02795% CI: [-5.49, -0.33]ANCOVA
Secondary
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
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).
Time frame: Baseline, 4 months, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 0.59 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| OEST | 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) | 0.85 units on a scale | Standard Deviation 0.726 |
| OEST | 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) | -0.31 units on a scale | Standard Deviation 0.723 |
| OEST | 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) | -0.32 units on a scale | Standard Deviation 0.728 |
| OEST | 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) | 0.50 units on a scale | Standard Deviation 0.538 |
| OEST | 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 0.529 |
| OEST | 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) | 0.97 units on a scale | Standard Deviation 0.602 |
| OEST | 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) | -0.32 units on a scale | Standard Deviation 0.513 |
| OEST | 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) | -0.30 units on a scale | Standard Deviation 0.521 |
| OEST | 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) | 0.67 units on a scale | Standard Deviation 0.499 |
| OEST | 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) | -0.03 units on a scale | Standard Deviation 0.371 |
| OEST | 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) | 0.96 units on a scale | Standard Deviation 0.453 |
| OEST | 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) | -0.35 units on a scale | Standard Deviation 0.357 |
| OEST | 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) | -0.36 units on a scale | Standard Deviation 0.363 |
| OEST | 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) | 0.59 units on a scale | Standard Deviation 0.344 |
| OEST | 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) | -0.02 units on a scale | Standard Deviation 0.252 |
| OEST | 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) | 1.19 units on a scale | Standard Deviation 0.728 |
| OEST | 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) | -0.45 units on a scale | Standard Deviation 0.591 |
| OEST | 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) | -0.44 units on a scale | Standard Deviation 0.599 |
| OEST | 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) | 0.72 units on a scale | Standard Deviation 0.557 |
| OEST | 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) | -0.04 units on a scale | Standard Deviation 0.44 |
| OEST | 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) | 1.07 units on a scale | Standard Deviation 0.519 |
| OEST | 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) | -0.25 units on a scale | Standard Deviation 0.427 |
| OEST | 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) | -0.27 units on a scale | Standard Deviation 0.427 |
| OEST | 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) | 0.81 units on a scale | Standard Deviation 0.429 |
| OEST | 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) | -0.03 units on a scale | Standard Deviation 0.365 |
| OEST | 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) | 0.45 units on a scale | Standard Deviation 0.383 |
| OEST | 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) | -0.17 units on a scale | Standard Deviation 0.272 |
| OEST | 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) | -0.18 units on a scale | Standard Deviation 0.269 |
| OEST | 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) | 0.25 units on a scale | Standard Deviation 0.302 |
| OEST | 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) | -0.02 units on a scale | Standard Deviation 0.207 |
| OEST | 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) | 1.18 units on a scale | Standard Deviation 0.617 |
| OEST | 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) | -0.57 units on a scale | Standard Deviation 0.563 |
| OEST | 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) | -0.60 units on a scale | Standard Deviation 0.565 |
| OEST | 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) | 0.53 units on a scale | Standard Deviation 0.444 |
| OEST | 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 0.389 |
p-value: 0.01595% CI: [0.014, 0.131]ANCOVA
p-value: 0.00495% CI: [0.027, 0.143]ANCOVA
p-value: 0.06395% CI: [-0.005, 0.192]ANCOVA
p-value: 0.13195% CI: [-0.022, 0.172]ANCOVA
p-value: 0.15695% CI: [-0.02, 0.124]ANCOVA
p-value: 0.04695% CI: [0.001, 0.143]ANCOVA
p-value: 0.06895% CI: [-0.003, 0.084]ANCOVA
p-value: 0.21295% CI: [-0.016, 0.073]ANCOVA
p-value: 0.00695% CI: [0.034, 0.208]ANCOVA
p-value: <0.00195% CI: [0.064, 0.236]ANCOVA
p-value: 0.03495% CI: [0.009, 0.24]ANCOVA
p-value: 0.0495% CI: [0.005, 0.233]ANCOVA
p-value: 0.04295% CI: [0.003, 0.166]ANCOVA
p-value: 0.27195% CI: [-0.038, 0.134]ANCOVA
Secondary
Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
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.
Time frame: Baseline, 4 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 10.6 |
| OEST | 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) | 10.7 T-Scores of units on a scale | Standard Deviation 11.32 |
| OEST | Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain | Month 6 Baseline (M6B) (n=132, n=148) | 41.2 T-Scores of units on a scale | Standard Deviation 12.28 |
| OEST | 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) | -0.9 T-Scores of units on a scale | Standard Deviation 9.51 |
p-value: 0.00295% CI: [-5.08, -1.13]ANCOVA
Secondary
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
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.
Time frame: Baseline, 6 months
Population: All randomized participants who received at least one dose of study drug and had non-missing values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |