Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.
Interventions
DRUGAtomoxetine
A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.
DRUGPlacebo
3 capsules of placebo have to be taken once daily in the morning, with or without food.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday * Diagnosis of ADHD * Normal intelligence * Able to swallow capsules
Exclusion criteria
* Weight less than 20 kg or more than 60 kg at study entry * Prior treatment with atomoxetine * History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months * History of severe allergies or multiple adverse drug reactions * Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline, 8 weeks (W8) | Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved\>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes\>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. |
| Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline, 8 weeks | Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms. |
| Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline, 8 weeks | Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. |
| Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline, 8 weeks | Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | Baseline, 8 weeks | CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). |
| Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Baseline, 8 weeks | Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3). |
| Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Baseline, 8 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. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine 0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose. | 63 |
| Placebo Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine | 62 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lack of Efficacy | 5 | 7 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Atomoxetine | Placebo | Total |
|---|---|---|---|
| ADHD Rating Scale-IV Parent Version: Investigator Administered & Scored, Total Score | 37.30 units on a scale STANDARD_DEVIATION 10.62 | 36.68 units on a scale STANDARD_DEVIATION 12.53 | 36.99 units on a scale STANDARD_DEVIATION 11.56 |
| Age Continuous | 9.1 years STANDARD_DEVIATION 1.93 | 8.9 years STANDARD_DEVIATION 1.64 | 9.0 years STANDARD_DEVIATION 1.79 |
| Clinical Global Impressions - Severity Of Attention Deficit Hyperactive Disorder Score | 5.11 units on a scale STANDARD_DEVIATION 1.02 | 5.05 units on a scale STANDARD_DEVIATION 1.11 | 5.08 units on a scale STANDARD_DEVIATION 1.06 |
| Diagnosis ADHD-Combined Type | 40 participants | 48 participants | 88 participants |
| Diagnosis ADHD- Predominantly Hyperactive-Impulsive Type | 6 participants | 3 participants | 9 participants |
| Diagnosis ADHD-Predominantly Inattentive Type | 17 participants | 11 participants | 28 participants |
| Number of Participants with Family History of ADHD At least one known relative with ADHD | 36 participants | 35 participants | 71 participants |
| Number of Participants with Family History of ADHD None or missing | 27 participants | 27 participants | 54 participants |
| Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD) None or missing | 37 participants | 35 participants | 72 participants |
| Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD) Previous treatment for ADHD | 26 participants | 27 participants | 53 participants |
| Number of Participants with Psychiatric Comorbidities At least one psychiatric comorbidity | 25 participants | 25 participants | 50 participants |
| Number of Participants with Psychiatric Comorbidities None or missing | 38 participants | 37 participants | 75 participants |
| Race/Ethnicity, Customized African | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Caucasian | 62 participants | 62 participants | 124 participants |
| Region of Enrollment Germany | 63 participants | 62 participants | 125 participants |
| Sex: Female, Male Female | 16 Participants | 12 Participants | 28 Participants |
| Sex: Female, Male Male | 47 Participants | 50 Participants | 97 Participants |
| Summary Of Participants' Living Arrangements Nuclear Family (Biological Mother and Father) | 38 participants | 36 participants | 74 participants |
| Summary Of Participants' Living Arrangements Single Mother | 15 participants | 17 participants | 32 participants |
| Summary Of Participants' Living Arrangements Step Parent (One Biologic and one step parent) | 10 participants | 9 participants | 19 participants |
| Time Since Initial Diagnosis Of ADHD | 1.8 years STANDARD_DEVIATION 2.23 | 1.6 years STANDARD_DEVIATION 1.89 | 1.7 years STANDARD_DEVIATION 2.06 |
| Time Since Onset Of ADHD Symptoms | 4.9 years STANDARD_DEVIATION 2.12 | 5.2 years STANDARD_DEVIATION 1.95 | 5.0 years STANDARD_DEVIATION 2.04 |
| Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores Evening Subscore | 14.54 units on a scale STANDARD_DEVIATION 4.76 | 15.39 units on a scale STANDARD_DEVIATION 4.74 | 14.96 units on a scale STANDARD_DEVIATION 4.75 |
| Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores Item 11 Subscore | 1.60 units on a scale STANDARD_DEVIATION 1.23 | 1.56 units on a scale STANDARD_DEVIATION 1.26 | 1.58 units on a scale STANDARD_DEVIATION 1.24 |
| Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores Morning Subscore | 5.56 units on a scale STANDARD_DEVIATION 2.66 | 4.63 units on a scale STANDARD_DEVIATION 2.92 | 5.10 units on a scale STANDARD_DEVIATION 2.82 |
| Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated, Total & Subscores Total Score | 21.70 units on a scale STANDARD_DEVIATION 7.64 | 21.58 units on a scale STANDARD_DEVIATION 7.91 | 21.64 units on a scale STANDARD_DEVIATION 7.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 63 | 27 / 62 |
| serious Total, serious adverse events | 0 / 63 | 0 / 62 |
Outcome results
Primary
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Time frame: Baseline, 8 weeks
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: CE- Morning | -0.68 Q-scores | Standard Deviation 1.34 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: CE- Noon | -0.65 Q-scores | Standard Deviation 1.29 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: CE- Evening | -0.80 Q-scores | Standard Deviation 1.23 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: CE- Morning | -0.88 Q-scores | Standard Deviation 1.33 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: CE- Noon | -0.94 Q-scores | Standard Deviation 1.33 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: CE- Evening | -0.76 Q-scores | Standard Deviation 1.31 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: AR- Morning | 0.41 Q-scores | Standard Deviation 1.15 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: AR- Noon | 0.28 Q-scores | Standard Deviation 1.06 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: AR- Evening | 0.32 Q-scores | Standard Deviation 1.16 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: AR- Morning | -0.50 Q-scores | Standard Deviation 0.98 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: AR-Noon | -0.54 Q-scores | Standard Deviation 0.87 |
| Atomoxetine | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: AR- Evening | -0.52 Q-scores | Standard Deviation 0.83 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: AR-Noon | -0.31 Q-scores | Standard Deviation 0.84 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: CE- Morning | -0.89 Q-scores | Standard Deviation 1.03 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: AR- Morning | 0.15 Q-scores | Standard Deviation 0.88 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: CE- Noon | -0.85 Q-scores | Standard Deviation 0.94 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: AR- Morning | -0.34 Q-scores | Standard Deviation 0.84 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: CE- Evening | -0.87 Q-scores | Standard Deviation 1.06 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: AR- Noon | 0.12 Q-scores | Standard Deviation 0.85 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: CE- Morning | -0.32 Q-scores | Standard Deviation 0.9 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: AR- Evening | -0.28 Q-scores | Standard Deviation 0.78 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: CE- Noon | -0.44 Q-scores | Standard Deviation 0.82 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | Baseline: AR- Evening | 0.08 Q-scores | Standard Deviation 0.85 |
| Placebo | Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 | W8: CE- Evening | -0.49 Q-scores | Standard Deviation 0.92 |
p-value: <0.00195% CI: [0.31, 0.68]Mixed Models Analysis
p-value: 0.02295% CI: [0.02, 0.31]Mixed Models Analysis
Primary
Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8
Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Time frame: Baseline, 8 weeks
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: OR- Morning | 1.12 Q-scores | Standard Deviation 1.24 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: RTV-Noon | 2.95 Q-scores | Standard Deviation 2.11 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: RTV-Evening | 2.63 Q-scores | Standard Deviation 2.49 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: RTV-Morning | -0.89 Q-scores | Standard Deviation 2.29 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: RTV-Noon | -1.07 Q-scores | Standard Deviation 1.92 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: RTV-Evening | -0.90 Q-scores | Standard Deviation 1.98 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: RTV-Morning | 2.93 Q-scores | Standard Deviation 2.41 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: OR- Noon | 1.31 Q-scores | Standard Deviation 1.32 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: OR- Evening | 1.22 Q-scores | Standard Deviation 1.43 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: OR- Morning | 0.01 Q-scores | Standard Deviation 1.83 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: OR- Noon | 0.03 Q-scores | Standard Deviation 1.45 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: OR- Evening | -0.04 Q-scores | Standard Deviation 1.5 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: mRT- Morning | 2.42 Q-scores | Standard Deviation 2.03 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: mRT- Noon | 2.40 Q-scores | Standard Deviation 1.78 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: mRT- Evening | 2.23 Q-scores | Standard Deviation 1.77 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: mRT- Morning | -0.18 Q-scores | Standard Deviation 1.84 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: mRT- Noon | -0.35 Q-scores | Standard Deviation 1.53 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: mRT- Evening | -0.13 Q-scores | Standard Deviation 1.4 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: nVRT-Morning | 1.00 Q-scores | Standard Deviation 1.6 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: nVRT-Noon | 1.06 Q-scores | Standard Deviation 1.48 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: nVRT-Evening | 0.92 Q-scores | Standard Deviation 1.81 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: nVRT-Morning | -0.59 Q-scores | Standard Deviation 1.58 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: nVRT-Noon | -0.65 Q-scores | Standard Deviation 1.48 |
| Atomoxetine | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: nVRT-Evening | -0.65 Q-scores | Standard Deviation 1.75 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: nVRT-Noon | -0.09 Q-scores | Standard Deviation 0.97 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: RTV-Morning | 2.49 Q-scores | Standard Deviation 1.62 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: mRT- Morning | 1.92 Q-scores | Standard Deviation 1.53 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: RTV-Noon | 2.48 Q-scores | Standard Deviation 1.92 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: nVRT-Morning | 0.93 Q-scores | Standard Deviation 1.28 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: RTV-Evening | 2.19 Q-scores | Standard Deviation 2 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: mRT- Noon | 2.02 Q-scores | Standard Deviation 1.49 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: RTV-Morning | -0.09 Q-scores | Standard Deviation 1.78 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: nVRT-Morning | -0.36 Q-scores | Standard Deviation 1.15 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: RTV-Noon | 0.00 Q-scores | Standard Deviation 1.7 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: mRT- Evening | 1.86 Q-scores | Standard Deviation 1.49 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: RTV-Evening | -0.00 Q-scores | Standard Deviation 1.88 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: nVRT-Noon | 0.82 Q-scores | Standard Deviation 1.26 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: OR- Morning | 1.13 Q-scores | Standard Deviation 1.19 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: mRT- Morning | 0.35 Q-scores | Standard Deviation 1.28 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: OR- Noon | 1.30 Q-scores | Standard Deviation 1.32 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: nVRT-Evening | -0.33 Q-scores | Standard Deviation 1.19 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: OR- Evening | 1.28 Q-scores | Standard Deviation 1.34 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: mRT- Noon | 0.12 Q-scores | Standard Deviation 1.42 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: OR- Morning | 0.54 Q-scores | Standard Deviation 1.14 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | Baseline: nVRT-Evening | 0.68 Q-scores | Standard Deviation 1.31 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: OR- Noon | 0.53 Q-scores | Standard Deviation 1.17 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: mRT- Evening | 0.48 Q-scores | Standard Deviation 1.37 |
| Placebo | Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 | W8: OR- Evening | 0.52 Q-scores | Standard Deviation 1.2 |
p-value: <0.00195% CI: [0.66, 1.35]Mixed Models Analysis
p-value: <0.00195% CI: [0.46, 0.93]Mixed Models Analysis
p-value: <0.00195% CI: [0.17, 0.65]Mixed Models Analysis
p-value: <0.00195% CI: [0.26, 0.73]Mixed Models Analysis
Primary
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Time frame: Baseline, 8 weeks
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: ER- Morning | 0.37 Q-scores | Standard Deviation 1.56 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: ER- Noon | 0.52 Q-scores | Standard Deviation 1.46 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: ER- Evening | 0.37 Q-scores | Standard Deviation 1.58 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: ER- Morning | -0.41 Q-scores | Standard Deviation 2.06 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: ER- Noon | -0.44 Q-scores | Standard Deviation 1.7 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: ER- Evening | -0.43 Q-scores | Standard Deviation 1.8 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: MR- Morning | -0.04 Q-scores | Standard Deviation 1.25 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: MR- Noon | 0.01 Q-scores | Standard Deviation 1.15 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: MR- Evening | 0.03 Q-scores | Standard Deviation 1.25 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: MR- Morning | -0.23 Q-scores | Standard Deviation 1.15 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: MR- Noon | -0.45 Q-scores | Standard Deviation 0.97 |
| Atomoxetine | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: MR- Evening | -0.35 Q-scores | Standard Deviation 1.3 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: MR- Noon | -0.16 Q-scores | Standard Deviation 0.83 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: ER- Morning | 0.30 Q-scores | Standard Deviation 1.15 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: MR- Morning | -0.26 Q-scores | Standard Deviation 0.84 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: ER- Noon | 0.41 Q-scores | Standard Deviation 1.24 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: MR- Morning | -0.24 Q-scores | Standard Deviation 0.78 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: ER- Evening | 0.41 Q-scores | Standard Deviation 1.24 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: MR- Noon | -0.30 Q-scores | Standard Deviation 0.95 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: ER- Morning | 0.35 Q-scores | Standard Deviation 1.1 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: MR- Evening | -0.16 Q-scores | Standard Deviation 0.77 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: ER- Noon | 0.32 Q-scores | Standard Deviation 1.06 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | Baseline: MR- Evening | -0.34 Q-scores | Standard Deviation 0.89 |
| Placebo | Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 | W8: ER- Evening | 0.28 Q-scores | Standard Deviation 1.1 |
p-value: <0.00195% CI: [0.69, 1.18]Mixed Models Analysis
p-value: 0.17895% CI: [0.05, 0.28]Mixed Models Analysis
Primary
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8
Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved\>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes\>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Time frame: Baseline, 8 weeks (W8)
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: AR- Morning | -0.38 Q-scores | Standard Deviation 1.58 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: DIS- Evening | 1.47 Q-scores | Standard Deviation 1.86 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: AR- Noon | -0.87 Q-scores | Standard Deviation 1.7 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: TA- Noon | 0.65 Q-scores | Standard Deviation 1.13 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: AR- Evening | -0.71 Q-scores | Standard Deviation 1.53 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: DIS- Morning | -0.51 Q-scores | Standard Deviation 1.8 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: ME- Morning | 0.97 Q-scores | Standard Deviation 1.32 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: TA- Evening | -0.55 Q-scores | Standard Deviation 1.08 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: ME- Noon | 0.98 Q-scores | Standard Deviation 1.29 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: DIS- Noon | -1.06 Q-scores | Standard Deviation 1.94 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: ME- Evening | 0.94 Q-scores | Standard Deviation 1.45 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: TA- Morning | -0.32 Q-scores | Standard Deviation 1 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: ME- Morning | -0.47 Q-scores | Standard Deviation 1.42 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: DIS- Evening | -0.87 Q-scores | Standard Deviation 1.71 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: ME- Noon | -0.82 Q-scores | Standard Deviation 1.48 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: DIS- Morning | 1.41 Q-scores | Standard Deviation 1.69 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: ME- Evening | -0.72 Q-scores | Standard Deviation 1.41 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: AR- Morning | 1.14 Q-scores | Standard Deviation 1.65 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: MS- Morning | 0.21 Q-scores | Standard Deviation 1.08 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: TA- Evening | 0.66 Q-scores | Standard Deviation 1.26 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: MS- Noon | 0.25 Q-scores | Standard Deviation 1.12 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: AR- Noon | 1.25 Q-scores | Standard Deviation 1.66 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: MS- Evening | 0.22 Q-scores | Standard Deviation 1.21 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: DIS- Noon | 1.55 Q-scores | Standard Deviation 1.86 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: MS- Morning | -0.22 Q-scores | Standard Deviation 1.29 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: AR- Evening | 1.19 Q-scores | Standard Deviation 1.81 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: MS- Noon | -0.39 Q-scores | Standard Deviation 1.37 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: TA- Noon | -0.60 Q-scores | Standard Deviation 1.13 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: MS- Evening | -0.38 Q-scores | Standard Deviation 1.31 |
| Atomoxetine | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: TA-Morning | 0.62 Q-scores | Standard Deviation 1.27 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: MS- Evening | -0.19 Q-scores | Standard Deviation 1.09 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: TA-Morning | 0.84 Q-scores | Standard Deviation 0.84 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: TA- Noon | 0.76 Q-scores | Standard Deviation 0.79 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: TA- Evening | 0.85 Q-scores | Standard Deviation 0.83 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: TA- Morning | 0.06 Q-scores | Standard Deviation 0.84 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: TA- Noon | 0.15 Q-scores | Standard Deviation 0.74 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: TA- Evening | 0.03 Q-scores | Standard Deviation 0.76 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: DIS- Morning | 1.62 Q-scores | Standard Deviation 1.68 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: DIS- Noon | 1.62 Q-scores | Standard Deviation 1.74 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: DIS- Evening | 1.75 Q-scores | Standard Deviation 1.73 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: DIS- Morning | 0.38 Q-scores | Standard Deviation 1.75 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: DIS- Noon | 0.49 Q-scores | Standard Deviation 1.52 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: DIS- Evening | 0.07 Q-scores | Standard Deviation 1.54 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: AR- Morning | 1.40 Q-scores | Standard Deviation 1.56 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: AR- Noon | 1.45 Q-scores | Standard Deviation 1.59 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: AR- Evening | 1.58 Q-scores | Standard Deviation 1.67 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: AR- Morning | 0.39 Q-scores | Standard Deviation 1.6 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: AR- Noon | 0.40 Q-scores | Standard Deviation 1.18 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: AR- Evening | -0.00 Q-scores | Standard Deviation 1.45 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: ME- Morning | 1.15 Q-scores | Standard Deviation 1.11 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: ME- Noon | 1.09 Q-scores | Standard Deviation 1.19 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: ME- Evening | 1.18 Q-scores | Standard Deviation 1.18 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: ME- Morning | 0.20 Q-scores | Standard Deviation 1.19 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: ME- Noon | 0.28 Q-scores | Standard Deviation 1.01 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: ME- Evening | 0.06 Q-scores | Standard Deviation 1.06 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: MS- Morning | 0.38 Q-scores | Standard Deviation 1.01 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: MS- Noon | 0.32 Q-scores | Standard Deviation 0.95 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | Baseline: MS- Evening | 0.35 Q-scores | Standard Deviation 1.05 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: MS- Morning | -0.04 Q-scores | Standard Deviation 1.07 |
| Placebo | Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 | W8 Change: MS- Noon | -0.12 Q-scores | Standard Deviation 0.94 |
p-value: <0.00195% CI: [0.52, 0.87]Mixed Models Analysis
p-value: <0.00195% CI: [0.98, 1.57]Mixed Models Analysis
p-value: <0.00195% CI: [0.81, 1.35]Mixed Models Analysis
p-value: <0.00195% CI: [0.78, 1.22]Mixed Models Analysis
p-value: <0.00195% CI: [0.18, 0.58]Mixed Models Analysis
Secondary
Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8
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.
Time frame: Baseline, 8 weeks
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Baseline to Visit 7 (Week 8) | -17.19 units on a scale | Standard Deviation 15.63 |
| Atomoxetine | Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Baseline to LOCF | -15.78 units on a scale | Standard Deviation 15.19 |
| Placebo | Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Baseline to Visit 7 (Week 8) | -4.76 units on a scale | Standard Deviation 11.51 |
| Placebo | Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 | Baseline to LOCF | -4.21 units on a scale | Standard Deviation 10.89 |
Comparison: Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)p-value: <0.00195% CI: [8.2, 14.99]Mixed Models Analysis
Secondary
Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
CGI-S-ADHD 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, 8 weeks
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | Baseline to Visit 7 (Week 8) | -1.78 units on a scale | Standard Deviation 1.61 |
| Atomoxetine | Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | Baseline to LOCF | -1.52 units on a scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | Baseline to Visit 7 (Week 8) | -0.63 units on a scale | Standard Deviation 1.11 |
| Placebo | Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 | Baseline to LOCF | -0.40 units on a scale | Standard Deviation 1.17 |
Comparison: Comparison of atomoxetine vs. placebo at Visit 7 (Week 8)p-value: <0.00195% CI: [0.76, 1.46]Mixed Models Analysis
Secondary
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
Weekly Rating Of Evening & Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).
Time frame: Baseline, 8 weeks
Population: Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Total Score: Baseline to Visit 7 (Week 8) | -10.72 units on a scale | Standard Deviation 10.21 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Total Score: Baseline to LOCF | -9.59 units on a scale | Standard Deviation 9.98 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Evening Subscore: Baseline to Visit 7 (Week 8) | -6.91 units on a scale | Standard Deviation 6.38 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Evening Subscore: Baseline to LOCF | -6.30 units on a scale | Standard Deviation 6.21 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Morning Subscore: Baseline to Visit 7 (Week 8) | -2.81 units on a scale | Standard Deviation 3.04 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Morning Subscore: Baseline to LOCF | -2.46 units on a scale | Standard Deviation 3 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Item 11 Subscore: Baseline to Visit 7 (Week 8) | -1.00 units on a scale | Standard Deviation 1.6 |
| Atomoxetine | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Item 11 Subscore: Baseline to LOCF | -0.83 units on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Item 11 Subscore: Baseline to LOCF | -0.23 units on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Total Score: Baseline to Visit 7 (Week 8) | -5.10 units on a scale | Standard Deviation 6.83 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Morning Subscore: Baseline to Visit 7 (Week 8) | -1.16 units on a scale | Standard Deviation 2.74 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Total Score: Baseline to LOCF | -3.90 units on a scale | Standard Deviation 7.83 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Item 11 Subscore: Baseline to Visit 7 (Week 8) | -0.37 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Evening Subscore: Baseline to Visit 7 (Week 8) | -3.57 units on a scale | Standard Deviation 4.36 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Morning Subscore: Baseline to LOCF | -0.65 units on a scale | Standard Deviation 2.94 |
| Placebo | Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 | Evening Subscore: Baseline to LOCF | -3.03 units on a scale | Standard Deviation 5.18 |
p-value: <0.00195% CI: [3.55, 7.92]Mixed Models Analysis
p-value: 0.00195% CI: [2.49, 5.44]Mixed Models Analysis
p-value: <0.00295% CI: [0.42, 1.93]Mixed Models Analysis
p-value: <0.00195% CI: [0.31, 0.93]Mixed Models Analysis