Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Children, Stimulant, Atomoxetine, Adolescents
Brief summary
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.
Detailed description
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.
Interventions
DRUGAtomoxetine
1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
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
* Outpatients between 6-16 years of age * Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD must be met * Normal laboratory and electrocardiogram (ECG) results * Normal intelligence * Must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy
Exclusion criteria
* Less than 20 kg or more than 70 kg at study entry * Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk * Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions * Taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor * Immediate need for stimulant discontinuation due to tolerability problems * Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint | Baseline, 10 weeks | 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 (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
| Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint | Baseline, 2 weeks | Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint | Baseline, 10 weeks | The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
| Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint | Baseline, 10 weeks | The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
| Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint | Baseline, 10 weeks | The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
| Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Baseline, 10 weeks | CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=\[(Score- Mean for the reference population \[Ref Pop\])\*10/SD for the Ref Pop\]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
| Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint | Baseline, 10 weeks | The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported. |
| Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint | Baseline, 6 weeks, 14 weeks | — |
| Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint | Baseline, 6 weeks, 14 weeks | — |
| Number of Participants With Suicidal Behaviors and Ideations | Baseline through 14 weeks | Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. |
| Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Baseline, 6 weeks, 14 weeks | — |
| Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint | Baseline, 10 weeks | The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction. |
Countries
Australia, Mexico, United Kingdom
Participant flow
Pre-assignment details
Study Period II was a 10-week treatment period. Study Period III was a 4-week period, during which participants continued on atomoxetine treatment in the same dose as given at the end of Study Period II or in a higher dose, up to a maximum of 1.8 mg/kg/day.
Participants by arm
| Arm | Count |
|---|---|
| Slow Switching Group Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks. | 57 |
| Fast Switching Group Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks. | 54 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Study Period II | Adverse Event | 3 | 4 |
| Study Period II | Lack of Efficacy | 0 | 6 |
| Study Period II | No drug administered | 0 | 1 |
| Study Period II | Parent/Caregiver Decision | 3 | 0 |
| Study Period II | Protocol Violation | 6 | 3 |
| Study Period II | Withdrawal by Subject | 1 | 0 |
| Study Period III | Adverse Event | 1 | 0 |
| Study Period III | Lack of Efficacy | 1 | 0 |
| Study Period III | Parent/Caregiver Decision | 0 | 1 |
| Study Period III | Physician Decision | 0 | 1 |
| Study Period III | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Slow Switching Group | Fast Switching Group |
|---|---|---|---|
| Age Continuous | 11.5 years STANDARD_DEVIATION 2.38 | 11.1 years STANDARD_DEVIATION 2.51 | 12.0 years STANDARD_DEVIATION 2.16 |
| Attention Deficit Hyperactivity Disorder (ADHD) subtype Combined | 74 participants | 38 participants | 36 participants |
| Attention Deficit Hyperactivity Disorder (ADHD) subtype Hyperactive/Impulsive | 4 participants | 1 participants | 3 participants |
| Attention Deficit Hyperactivity Disorder (ADHD) subtype Inattentive | 32 participants | 17 participants | 15 participants |
| Attention Deficit Hyperactivity Disorder (ADHD) subtype Not otherwise categorized | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized African | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 89 Participants | 46 Participants | 43 Participants |
| Race/Ethnicity, Customized Hispanic | 21 Participants | 10 Participants | 11 Participants |
| Region of Enrollment Australia | 12 participants | 7 participants | 5 participants |
| Region of Enrollment Mexico | 20 participants | 10 participants | 10 participants |
| Region of Enrollment Portugal | 7 participants | 3 participants | 4 participants |
| Region of Enrollment Spain | 57 participants | 29 participants | 28 participants |
| Region of Enrollment United Kingdom | 15 participants | 8 participants | 7 participants |
| Sex: Female, Male Female | 18 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Male | 93 Participants | 49 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 57 | 30 / 54 |
| serious Total, serious adverse events | 1 / 57 | 1 / 54 |
Outcome results
Primary
Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 2 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint | -8.0 units on a scale | Standard Error 1 |
| Fast Switching Group | Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint | -8.1 units on a scale | Standard Error 1 |
p-value: 0.92795% CI: [-2.9, 2.6]Mixed Models Analysis
Primary
Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint
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 (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint | -14.3 units on a scale | Standard Error 1.2 |
| Fast Switching Group | Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint | -15.0 units on a scale | Standard Error 1.2 |
p-value: 0.69295% CI: [-4, 2.6]Mixed Models Analysis
Secondary
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint
Time frame: Baseline, 6 weeks, 14 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Slow Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 6 Change Diastolic BP (n=52, 52) | 1.5 mmHg | Standard Deviation 7.21 |
| Slow Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 6 Change Systolic BP (n=52, 52) | 1.2 mmHg | Standard Deviation 7.74 |
| Slow Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 14 Change Diastolic BP (n=43, 40) | 2.3 mmHg | Standard Deviation 7.58 |
| Slow Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 14 Change Systolic BP (n= 43, 40) | -0.2 mmHg | Standard Deviation 8.62 |
| Fast Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 14 Change Systolic BP (n= 43, 40) | 2.6 mmHg | Standard Deviation 9 |
| Fast Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 6 Change Diastolic BP (n=52, 52) | 1.9 mmHg | Standard Deviation 8.31 |
| Fast Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 14 Change Diastolic BP (n=43, 40) | 3.1 mmHg | Standard Deviation 7.04 |
| Fast Switching Group | Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint | Week 6 Change Systolic BP (n=52, 52) | 0.5 mmHg | Standard Deviation 9.05 |
Secondary
Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint
Time frame: Baseline, 6 weeks, 14 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Slow Switching Group | Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint | Week 6 Change (n=52, 52) | -0.4 kilogram | Standard Deviation 1.12 |
| Slow Switching Group | Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint | Week 14 Change (n=43, 40) | 0.6 kilogram | Standard Deviation 1.64 |
| Fast Switching Group | Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint | Week 6 Change (n=52, 52) | 0.6 kilogram | Standard Deviation 1.25 |
| Fast Switching Group | Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint | Week 14 Change (n=43, 40) | 1.1 kilogram | Standard Deviation 2.15 |
Secondary
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint
CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=\[(Score- Mean for the reference population \[Ref Pop\])\*10/SD for the Ref Pop\]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Slow Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Satisfaction Domain | 3.4 standard deviation units | Standard Error 1.6 |
| Slow Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Risk Avoidance Domain | 4.9 standard deviation units | Standard Error 1.4 |
| Slow Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Comfort Domain | 0.7 standard deviation units | Standard Error 1.2 |
| Slow Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Resilience Domain | 1.8 standard deviation units | Standard Error 1.4 |
| Slow Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Achievement Domain | 3.5 standard deviation units | Standard Error 1.7 |
| Fast Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Resilience Domain | -1.0 standard deviation units | Standard Error 1.4 |
| Fast Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Achievement Domain | -1.2 standard deviation units | Standard Error 1.6 |
| Fast Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Satisfaction Domain | 2.2 standard deviation units | Standard Error 1.6 |
| Fast Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Comfort Domain | 4.1 standard deviation units | Standard Error 1.1 |
| Fast Switching Group | Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint | Risk Avoidance Domain | 2.9 standard deviation units | Standard Error 1.4 |
Secondary
Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint
The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint | -1.7 units on a scale | Standard Error 0.2 |
| Fast Switching Group | Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint | -1.7 units on a scale | Standard Error 0.2 |
p-value: 0.89895% CI: [-0.4, 0.4]Mixed Models Analysis
Secondary
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint
The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint | -1.3 units on a scale | Standard Error 0.2 |
| Fast Switching Group | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint | -1.2 units on a scale | Standard Error 0.2 |
p-value: 0.52695% CI: [-0.3, 0.6]Mixed Models Analysis
Secondary
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint
The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint | -1.0 units on a scale | Standard Error 0.2 |
| Fast Switching Group | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint | -0.8 units on a scale | Standard Error 0.2 |
p-value: 0.51795% CI: [-0.3, 0.7]Mixed Models Analysis
Secondary
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint
The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint | -0.6 units on a scale | Standard Error 0.2 |
| Fast Switching Group | Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint | -0.4 units on a scale | Standard Error 0.2 |
p-value: 0.45695% CI: [-0.3, 0.7]Mixed Models Analysis
Secondary
Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint
Time frame: Baseline, 6 weeks, 14 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Slow Switching Group | Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint | Week 6 Change (n=52, 52) | 6.8 beats per minute | Standard Deviation 11.12 |
| Slow Switching Group | Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint | Week 14 Change (n=43, 40) | 3.4 beats per minute | Standard Deviation 12.69 |
| Fast Switching Group | Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint | Week 6 Change (n=52, 52) | 4.2 beats per minute | Standard Deviation 8.83 |
| Fast Switching Group | Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint | Week 14 Change (n=43, 40) | 5.9 beats per minute | Standard Deviation 10.17 |
Secondary
Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint
The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.
Time frame: Baseline, 10 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Slow Switching Group | Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint | -0.7 units on a scale | Standard Deviation 1.16 |
| Fast Switching Group | Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint | -0.5 units on a scale | Standard Deviation 1.11 |
Secondary
Number of Participants With Suicidal Behaviors and Ideations
Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Time frame: Baseline through 14 weeks
Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Slow Switching Group | Number of Participants With Suicidal Behaviors and Ideations | 1 participants |
| Fast Switching Group | Number of Participants With Suicidal Behaviors and Ideations | 1 participants |