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Trial record 5 of 10804 for:    Placebo AND once

A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT00190775
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : October 21, 2010
Last Update Posted : August 22, 2011
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Atomoxetine Hydrochloride
Drug: Placebo
Enrollment 502
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Period Title: Overall Study
Started 268 234
Received Study Drug 266 234
Completed 119 134
Not Completed 149 100
Reason Not Completed
Adverse Event             57             22
Satisfactory Response             1             0
Lack of Efficacy             28             32
Lost to Follow-up             31             23
Participant Moved             0             1
Withdrawal by Subject             24             13
Sponsor Decision             1             0
Physician Decision             3             0
Noncompliance             3             5
Protocol Violation             0             1
Exclusion Criteria Met             1             3
Arm/Group Title Atomoxetine Placebo Total
Hide Arm/Group Description Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally Total of all reporting groups
Overall Number of Baseline Participants 268 234 502
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 268 participants 234 participants 502 participants
41.21  (6.89) 41.39  (7.49) 41.30  (7.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 234 participants 502 participants
Female
131
  48.9%
132
  56.4%
263
  52.4%
Male
137
  51.1%
102
  43.6%
239
  47.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 268 participants 234 participants 502 participants
Hispanic 24 20 44
Caucasian 227 199 426
African Descent 11 6 17
East/Southeast Asian 0 2 2
Western Asian 1 0 1
Other 5 7 12
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 268 participants 234 participants 502 participants
United States 255 224 479
Puerto Rico 13 10 23
Attention Deficit Hyperactivity Disorder (ADHD) Subtype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 268 participants 234 participants 502 participants
Combined 179 166 345
Inattentive 89 67 156
Hyperactive/Impulsive 0 1 1
Previous Stimulant Exposure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 268 participants 234 participants 502 participants
Yes 47 35 82
No 220 198 418
Unknown or Not Reported 1 1 2
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
AISRS Total Score 36.07  (7.64) 36.59  (8.34) 36.31  (7.97)
AISRS Inattention Score 20.91  (3.83) 20.62  (4.02) 20.77  (3.92)
AISRS Hyperactivity Score 15.16  (5.75) 15.97  (5.94) 15.54  (5.85)
[1]
Measure Description: 18-item scale that captures the 18-item Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) symptoms of ADHD. 9 inattentive items alternate with 9 hyperactive/impulsive items. Each item is scored 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The total score range is 0-54 (0-27 for each subscale). Higher scores indicate more impaired participants. The scale was administered by a physician or PhD at the investigative site.
Alabama Parenting Questionnaire (APQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Child Involvement Mother 35.30  (6.02) 36.09  (5.90) 35.67  (5.97)
Child Involvement Father 31.50  (6.85) 32.35  (6.86) 31.90  (6.86)
Child Positive Parenting 23.85  (4.04) 23.40  (4.02) 23.64  (4.03)
Child Poor Monitoring/Supervision 16.93  (4.92) 17.27  (5.34) 17.09  (5.12)
Child Inconsistent Discipline 12.66  (3.44) 13.01  (3.57) 12.83  (3.50)
Child Corporal Punishment 4.86  (2.08) 4.99  (2.37) 4.92  (2.22)
Child Other Discipline Practice 17.62  (3.52) 18.18  (3.88) 17.88  (3.70)
Parent Involvement 37.71  (5.11) 37.61  (5.62) 37.67  (5.34)
Parent Positive Parenting 24.53  (3.26) 24.06  (3.58) 24.31  (3.42)
Parent Poor Monitoring Supervision 16.64  (4.91) 16.50  (4.78) 16.58  (4.85)
Parent Inconsistent Discipline 15.37  (3.44) 15.48  (3.42) 15.42  (3.42)
Parent Corporal Punishment 4.73  (1.60) 4.75  (1.76) 4.74  (1.67)
Parent Other Discipline Practice 19.53  (3.08) 19.64  (2.96) 19.58  (3.02)
Parent Dysfunctional Parenting Composite 0.12  (0.98) 0.17  (1.01) 0.14  (0.99)
Parent Negative Parenting 0.21  (1.05) 0.21  (0.99) 0.21  (1.02)
Parent Positive Parenting -0.00  (0.95) -0.07  (1.05) -0.04  (1.00)
[1]
Measure Description: 42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/square meters
Number Analyzed 268 participants 234 participants 502 participants
30.15  (6.58) 29.31  (6.51) 29.76  (6.56)
[1]
Measure Description: Body mass index (BMI) is an estimate of body fat based on body weight divided by height squared.
Child Disruptive Behavior Rating Scale (CDBRS) Parent Form   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Total Score 24.56  (13.30) 24.35  (13.01) 24.46  (13.16)
Inattention Symptom ADHD Score 13.39  (7.30) 13.35  (6.86) 13.37  (7.09)
Hyperactive-Impulsive Symptom ADHD Score 11.17  (6.98) 11.00  (6.95) 11.09  (6.96)
[1]
Measure Description: Child Disruptive Behavior Rating Scale (CDBRS) contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscore). Higher scores indicate greater impairment. Participants with a child aged 6-12 or 13-17 years old living in the home completed the scale.
Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
4.56  (0.62) 4.58  (0.60) 4.57  (0.61)
[1]
Measure Description: The CGI-ADHD-S is a single-item rating of the clinician’s assessment of the severity of ADHD symptoms in relation to the clinician’s total experience with ADHD subjects. Severity is rated on a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill subjects). The scale was administered by a physician or PhD at the investigative site.
Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Total ADHD Symptoms Score 34.64  (8.39) 35.50  (8.53) 35.04  (8.46)
Inattention Subscale 19.97  (4.45) 19.90  (4.33) 19.94  (4.39)
Hyper/Impulsive Subscale 14.67  (5.89) 15.60  (5.80) 15.11  (5.86)
Index Subscale 21.60  (5.37) 21.49  (5.74) 21.55  (5.54)
[1]
Measure Description: 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Dyadic Adjustment Scale (DAS) - Participant (Self)   [1] 
Mean (Standard Deviation)
Unit of measure:  T-scores of units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Total Dyadic Adjustment 43.06  (11.90) 42.37  (11.11) 42.74  (11.53)
Affectional Expression 43.70  (12.52) 44.85  (11.68) 44.24  (12.14)
Dyadic Cohesion 52.51  (10.63) 51.58  (10.02) 52.08  (10.35)
Dyadic Consensus 44.99  (9.22) 44.26  (8.69) 44.65  (8.98)
Dyadic Satisfaction 42.98  (10.82) 42.49  (10.24) 42.75  (10.55)
[1]
Measure Description: 32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other   [1] 
Mean (Standard Deviation)
Unit of measure:  T-scores of units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Total Dyadic Adjustment 41.93  (11.44) 41.75  (11.29) 41.85  (11.36)
Affectational Expression 43.18  (11.97) 43.66  (12.28) 43.41  (12.10)
Dyadic Cohesion 51.35  (11.09) 51.70  (10.30) 51.51  (10.72)
Dyadic Consensus 40.82  (10.18) 40.44  (10.02) 40.64  (10.10)
Dyadic Satisfaction 42.25  (10.75) 41.84  (10.53) 42.06  (10.64)
[1]
Measure Description: 32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self)   [1] 
Mean (Standard Deviation)
Unit of measure:  T-scores of units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Task Accomplishment 62.78  (5.56) 62.38  (5.43) 62.59  (5.50)
Role Performance 60.81  (5.03) 61.13  (5.75) 60.96  (5.37)
Communication 64.97  (6.49) 64.24  (6.35) 64.63  (6.43)
Affective Expression 61.48  (8.63) 61.71  (9.47) 61.59  (9.02)
Involvement 64.07  (7.92) 64.59  (7.35) 64.31  (7.66)
Control 62.70  (5.95) 62.13  (6.07) 62.43  (6.01)
Values and Norms 65.66  (6.70) 64.90  (7.44) 65.30  (7.06)
[1]
Measure Description: FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other   [1] 
Mean (Standard Deviation)
Unit of measure:  T-scores of units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Task Accomplishment 61.52  (5.97) 60.90  (5.83) 61.23  (5.91)
Role Performance 61.28  (5.67) 60.59  (6.00) 60.96  (5.83)
Communication 64.05  (6.37) 63.47  (7.02) 63.78  (6.68)
Affective Expression 61.97  (9.67) 61.68  (9.07) 61.84  (9.39)
Involvement 64.96  (8.95) 64.52  (8.77) 64.76  (8.86)
Control 61.98  (6.52) 61.34  (6.25) 61.68  (6.40)
Values and Norms 65.32  (7.11) 65.52  (7.17) 65.41  (7.13)
[1]
Measure Description: FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 268 participants 234 participants 502 participants
171.23  (10.37) 170.01  (9.74) 170.66  (10.09)
Montgomery-Asberg Depression Rating Scale Total Score (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
8.13  (4.80) 8.12  (5.01) 8.13  (4.89)
[1]
Measure Description: The MADRS is an investigator administered rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Parent Stress Index (PSI) Total Stress and Life Stress   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Total Stress 285.40  (53.45) 277.11  (52.65) 281.53  (53.18)
Life Stress 1.57  (3.56) 1.76  (3.68) 1.66  (3.62)
[1]
Measure Description: The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Parent Stress Index (PSI) Parent Domains   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Parent Domain Total 135.40  (25.22) 130.22  (24.62) 132.98  (25.05)
Parent Domain Role Restriction 18.93  (5.33) 18.26  (4.99) 18.62  (5.18)
Parent Domain Depression 22.79  (6.10) 21.01  (5.68) 21.96  (5.97)
Parent Domain Spouse 18.19  (5.03) 18.14  (5.04) 18.17  (5.03)
Parent Domain Competence 32.63  (6.69) 31.78  (7.10) 32.23  (6.89)
Parent Domain Isolation 15.49  (4.71) 14.56  (4.61) 15.06  (4.68)
Parent Domain Attachment 13.74  (4.21) 12.95  (3.61) 13.37  (3.96)
Parent Domain Health 13.72  (2.71) 13.52  (2.62) 13.63  (2.67)
[1]
Measure Description: 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Parent Stress Index (PSI) Child Domains   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Child Domain Total 150.00  (34.46) 146.88  (34.44) 148.54  (34.45)
Child Domain Distractibility/Hyperactivity 27.49  (6.46) 27.59  (6.48) 27.54  (6.47)
Child Domain Adaptability 48.29  (11.56) 47.59  (12.28) 47.96  (11.89)
Child Domain Reinforces Parent 24.87  (7.13) 23.75  (7.07) 24.34  (7.12)
Child Domain Demandingness 20.99  (6.09) 20.71  (6.48) 20.85  (6.27)
Child Domain Mood 12.42  (3.89) 12.06  (4.03) 12.25  (3.96)
Child Domain Acceptability 15.94  (4.75) 15.18  (4.67) 15.59  (4.72)
[1]
Measure Description: 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Parenting Sense of Competence (PSOC) Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
Total 58.64  (9.83) 60.80  (9.18) 59.65  (9.58)
Satisfaction Scale 33.46  (6.58) 34.94  (6.38) 34.15  (6.52)
Efficacy Scale 25.18  (4.72) 25.86  (4.31) 25.50  (4.54)
[1]
Measure Description: 16-item scale to assess parenting self-esteem: the Satisfaction Subscale has 9 questions (2,3,4,5,8,9,12,14,16)=54; the Efficacy Subscale has 7 questions (1,6,7,10,11,13,15)=43. Each response on the satisfaction subscale is answered on a 6-point scale (strongly agree/strongly disagree). Higher scores indicate greater satisfaction and greater self-efficacy. Lower scores mean more impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
State-Trait Anxiety Inventories (STAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 268 participants 234 participants 502 participants
State Anxiety Score 40.13  (11.55) 41.16  (11.18) 40.61  (11.38)
Trait Anxiety Score 47.44  (10.68) 46.05  (11.22) 46.79  (10.94)
[1]
Measure Description: Self-report scale completed by the participant. Separate scales measure state (20 items) and trait (20 items) anxiety. The participant reports how they feel “right now at this moment” for state anxiety and how they “generally” feel for trait anxiety. The “state” items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The “trait” items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). Scores range from 4-80 for each scale. Higher scores indicate more impaired participants.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 268 participants 234 participants 502 participants
88.22  (20.40) 84.84  (19.72) 86.65  (20.14)
1.Primary Outcome
Title Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
Hide Description 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 125 136
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-16.43  (0.88) -8.65  (0.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.78
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.11
Estimation Comments Least Squares Mean Difference = Atomoxetine - Placebo.
2.Primary Outcome
Title Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score
Hide Description 30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included. The protocol was amended to extend the open-label portion of the study from 8 weeks to 12 weeks, and the primary objective was modified to include the CAARS-IV:SV at 12 weeks.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 180 165
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-14.33  (0.83) -10.05  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Model included visit, baseline, treatment, pooled investigator, child with ADHD, and treatment by visit.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments Least Squares Mean Difference = Atomoxetine - Placebo.
3.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
Hide Description FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Task Accomplishment -0.79  (6.66) -0.41  (6.37)
Role Performance -0.25  (5.30) -0.04  (6.18)
Communication -0.63  (7.50) -0.29  (6.88)
Affective Expression 0.50  (7.75) -0.33  (7.86)
Involvement -0.27  (7.79) 0.17  (7.54)
Control -0.01  (6.64) 0.33  (6.56)
Values and Norms 0.00  (6.97) -0.27  (8.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments P-Value for Task Accomplishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.491
Comments P-Value for Role Performance.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.600
Comments P-Value for Communication.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.052
Comments P-Value for Affective Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.514
Comments P-Value for Involvement.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments P-Value for Control.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments P-Value for Values and Norms.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
4.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
Hide Description FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Task Accomplishment -0.81  (6.45) -0.90  (6.59)
Role Performance -0.33  (5.60) 0.27  (6.65)
Communication -1.15  (7.49) -0.58  (6.73)
Affective Expression 0.05  (8.31) 0.25  (8.10)
Involvement -0.32  (7.68) 0.56  (7.32)
Control -0.53  (6.89) 0.41  (6.21)
Values and Norms -0.67  (7.15) 0.31  (8.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments P-Value for Task Accomplishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments P-Value for Role Performance.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.931
Comments P-Value for Communication.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.788
Comments P-Value for Affective Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments P-Value for Involvement.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.360
Comments P-Value for Control.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments P-Value for Values and Norms.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
5.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
Hide Description FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Task Accomplishment -0.28  (6.57) 0.15  (7.10)
Role Performance -0.86  (5.86) -0.35  (6.33)
Communication -0.15  (7.24) -0.05  (7.21)
Affective Expression 0.17  (8.30) 0.32  (8.83)
Involvement -0.25  (7.50) 0.11  (7.81)
Control 0.15  (6.46) 0.54  (6.78)
Values and Norms -0.27  (8.15) -0.95  (7.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments P-Value for Task Accomplishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.705
Comments P-Value for Role Performance.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.686
Comments P-Value for Communication.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.618
Comments P-Value for Affective Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.903
Comments P-Value for Involvement.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments P-Value for Control.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.403
Comments P-Value for Values and Norms.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
6.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
Hide Description FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores >=60 indicate disturbance in family functioning.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Task Accomplishment -0.79  (6.94) 0.24  (6.99)
Role Performance -0.93  (6.03) -0.41  (6.37)
Communication 0.14  (7.09) -0.09  (7.17)
Affective Expression -0.08  (8.02) 0.60  (8.79)
Involvement -0.47  (7.88) -0.10  (7.69)
Control 0.05  (7.15) 0.73  (6.69)
Values and Norms -0.19  (8.00) -0.57  (7.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.941
Comments P-Value for Task Accomplishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.788
Comments P-Value for Role Performance.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.391
Comments P-Value for Communication.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments P-Value for Affective Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.774
Comments P-Value for Involvement.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.360
Comments P-Value for Control.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments P-Value for Values and Norms.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
7.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
Hide Description 32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Total Dyadic Adjustment 1.13  (6.33) 0.70  (6.55)
Dyadic Consensus 1.61  (6.77) 1.42  (7.22)
Dyadic Satisfaction 0.52  (6.22) -0.02  (5.53)
Affectional Expression 1.16  (9.00) -0.85  (8.27)
Dyadic Cohesion -0.06  (7.65) 0.54  (6.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments P-Value for Total Dyadic Adjustment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments P-Value for Dyadic Consensus.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments P-Value for Dyadic Satisfaction.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments P-Value for Affectional Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.405
Comments P-Value for Dyadic Cohesion.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
8.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
Hide Description 32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Total Dyadic Adjustment 1.21  (7.12) 0.51  (7.74)
Dyadic Consensus 2.13  (6.97) 1.58  (8.34)
Dyadic Satisfaction 0.47  (6.83) -0.32  (6.13)
Affectional Expression 0.62  (9.09) -1.13  (9.93)
Dyadic Cohesion 0.30  (7.92) 0.16  (8.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments P-Value for Total Dyadic Adjustment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.494
Comments P-Value for Dyadic Consensus.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.547
Comments P-Value for Dyadic Satisfaction.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments P-Value for Affectional Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments P-Value for Dyadic Cohesion.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
9.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other
Hide Description 32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 246 215
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Total Dyadic Adjustment 2.09  (6.37) 2.64  (7.13)
Dyadic Consensus 2.49  (6.84) 3.67  (7.92)
Dyadic Satisfaction 1.37  (5.81) 1.61  (6.36)
Affectional Expression 1.57  (9.40) 1.23  (9.57)
Dyadic Cohesion 0.81  (7.33) 0.29  (8.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments P-Value for Total Dyadic Adjustment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments P-Value for Dyadic Consensus.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.795
Comments P-Value for Dyadic Satisfaction.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.955
Comments P-Value for Affectional Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.788
Comments P-Value for Dyadic Cohesion.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
10.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other
Hide Description 32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores <30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 246 215
Mean (Standard Deviation)
Unit of Measure: T-scores of units on a scale
Total Dyadic Adjustment 2.09  (6.97) 2.84  (6.80)
Dyadic Consensus 2.79  (7.49) 3.87  (7.22)
Dyadic Satisfaction 1.32  (6.17) 1.27  (6.47)
Affectional Expression 1.38  (10.08) 2.00  (8.00)
Dyadic Cohesion 0.87  (7.70) 0.99  (7.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments P-Value for Total Dyadic Adjustment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.163
Comments P-Value for Dyadic Consensus.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.947
Comments P-Value for Dyadic Satisfaction.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.214
Comments P-Value for Affectional Expression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.543
Comments P-Value for Dyadic Cohesion.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
11.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress
Hide Description The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total Stress -10.74  (32.14) -7.06  (26.63)
Life Stress 0.25  (4.22) -0.30  (4.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.446
Comments P-Value for Total Stress.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments P-Value for Life Stress.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
12.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains
Hide Description 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Parent Domain Total -5.08  (17.40) -1.34  (12.95)
Parent Domain Competence -1.78  (5.29) -1.24  (4.26)
Parent Domain Isolation -0.68  (3.55) -0.11  (2.97)
Parent Domain Attachment 0.05  (3.34) 0.40  (2.74)
Parent Domain Health 0.05  (2.48) -0.05  (2.18)
Parent Domain Role Restriction -0.51  (4.07) 0.06  (3.75)
Parent Domain Depression -1.55  (4.70) -0.08  (3.78)
Parent Domain Spouse -0.74  (3.63) -0.32  (3.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments P-Value for Parent Domain Total.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.459
Comments P-Value for Parent Domain Competence.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.435
Comments P-Value for Parent Domain Isolation.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments P-Value for Parent Domain Attachment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments P-Value for Parent Domain Health.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.176
Comments P-Value for Parent Domain Role Restriction.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments P-Value for Parent Domain Depression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.434
Comments P-Value for Parent Domain Spouse.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
13.Secondary Outcome
Title Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains
Hide Description 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Child Domain Total -5.66  (19.12) -5.72  (18.62)
Defensive Responding -1.66  (5.48) -0.35  (4.75)
Child Domain Distractibility/Hyperactive -1.70  (4.15) -1.93  (4.11)
Child Domain Adaptability -1.56  (6.92) -1.87  (7.23)
Child Domain Reinforces Parent -0.79  (4.98) -0.32  (4.44)
Child Domain Demandingness -0.56  (3.78) -1.00  (3.99)
Child Domain Mood -0.36  (2.63) -0.26  (2.67)
Child Domain Acceptability -0.68  (3.48) -0.34  (3.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.578
Comments P-Value for Child Domain Total.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments P-Value for Defensive Responding.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments P-Value for Child Domain Distractibility/Hyperactive.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.383
Comments P-Value for Child Domain Adaptability.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.963
Comments P-Value for Child Domain Reinforces Parent.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.075
Comments P-Value for Child Domain Demandingness.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments P-Value for Child Domain Mood.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.671
Comments P-Value for Child Domain Acceptability.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
14.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress
Hide Description The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score >=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (>=85th percentile) indicate higher stress. Total Stress >=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total Stress -17.19  (40.19) -10.97  (31.33)
Life Stress 0.99  (4.91) 0.19  (4.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments P-Value for Total Stress.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments P-Value for Life Stress.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
15.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains
Hide Description 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics’ subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score >=148 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Parent Domain Total -7.66  (21.45) -3.12  (15.18)
Parent Domain Competence -2.58  (5.77) -1.57  (4.54)
Parent Domain Isolation -1.08  (3.61) -0.28  (3.17)
Parent Domain Attachment -0.19  (3.53) -0.01  (2.57)
Parent Domain Health -0.09  (2.75) 0.07  (2.45)
Parent Domain Role Restriction -0.52  (4.58) -0.31  (4.00)
Parent Domain Depression -2.13  (5.29) -0.54  (4.29)
Parent Domain Spouse -0.75  (4.22) -0.48  (3.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments P-Value for Parent Domain Total.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments P-Value for Parent Domain Competence.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments P-Value for Parent Domain Isolation.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.472
Comments P-Value for Parent Domain Attachment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments P-Value for Parent Domain Health.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.848
Comments P-Value for Parent Domain Role Restriction.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments P-Value for Parent Domain Depression.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.840
Comments P-Value for Parent Domain Spouse.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
16.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains
Hide Description 120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics’ subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score >=116 (>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 262 227
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Child Domain Total -9.52  (22.92) -7.85  (20.07)
Defensive Responding -2.28  (6.44) -0.84  (5.20)
Child Domain Distractibility/Hyperactive -2.28  (4.24) -2.60  (4.35)
Child Domain Adaptability -2.66  (7.95) -2.44  (7.28)
Child Domain Reinforces Parent -1.54  (5.58) -0.63  (4.96)
Child Domain Demandingness -1.06  (4.14) -1.30  (4.19)
Child Domain Mood -0.72  (2.89) -0.33  (3.02)
Child Domain Acceptability -0.91  (3.75) -0.56  (3.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.785
Comments P-Value for Child Domain Total.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments P-Value for Defensive Responding.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.518
Comments P-Value for Child Domain Distractibility/Hyperactive.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.883
Comments P-Value for Child Domain Adaptability.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.439
Comments P-Value for Child Domain Reinforces Parent.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments P-Value for Child Domain Demandingness.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments P-Value for Child Domain Mood.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments P-Value for Child Domain Acceptability.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
17.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
Hide Description 42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 230 192
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Parent Involvement (n=230, 192) 0.27  (3.96) 0.67  (3.57)
Parent Positive Parenting (n=230, 192) 0.00  (2.59) 0.36  (2.33)
Parent Poor Supervision (n=229, 191) -1.29  (3.39) -1.17  (3.43)
Parent Inconsistent Discipline (n=230, 192) -1.07  (2.78) -0.81  (2.59)
Parent Corporal Punishment (n=230, 192) -0.23  (1.36) -0.21  (1.00)
Parent Other Discipline Practice (n=230, 190) -0.01  (2.51) 0.00  (2.57)
Dysfunctional Parenting Composite (n=229, 191) -0.23  (0.77) -0.26  (0.65)
Negative Parenting Composite (n=229, 191) -0.37  (0.79) -0.32  (0.74)
Positive Parenting Composite (n=230, 192) 0.03  (0.72) 0.13  (0.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.420
Comments P-Value for Parent Involvement.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments P-Value for Parent Positive Parenting.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.927
Comments P-Value for Parent Poor Supervision.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments P-Value for Parent Inconsistent Discipline.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.673
Comments P-Value for Parent Corporal Punishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.881
Comments P-Value for Parent Other Discipline Practice.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments P-Value for Dysfunctional Parenting Composite.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.498
Comments P-Value for Negative Parenting Composite.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.283
Comments P-Value for Positive Parenting Composite.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
18.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
Hide Description 42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 230 292
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Parent Involvement (n=230, 192) 0.31  (3.84) 0.43  (3.47)
Parent Positive Parenting (n=230, 192) 0.07  (2.83) 0.11  (2.35)
Parent Poor Supervision (n=229, 191) -1.24  (3.89) -0.96  (3.31)
Inconsistent Discipline (n=230, 192) -1.19  (2.94) -0.82  (2.75)
Parent Corporal Punishment (n=230, 192) -0.25  (1.34) -0.14  (1.17)
Other Discipline Practice (n=230, 190) 0.22  (2.67) 0.18  (2.27)
Dysfunctional Parenting Composite (n=229, 191) -0.25  (0.80) -0.20  (0.56)
Negative Parenting Composite (n=229, 191) -0.39  (0.86) -0.28  (0.71)
Positive Parenting Composite (n=230, 192) 0.05  (0.74) 0.07  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.784
Comments P-Value for Parent Involvement.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.864
Comments P-Value for Parent Positive Parenting.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments P-Value for Parent Poor Supervision.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments P-Value for Parent Inconsistent Discipline.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.120
Comments P-Value for Parent Corporal Punishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.925
Comments P-Value Other Discipline Practice.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.444
Comments P-Value for Dysfunctional Parenting Composite.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments P-Value for Negative Parenting Composite.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments P-Value for Positive Parenting Composite.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
19.Secondary Outcome
Title Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
Hide Description 42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 189 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Child Involvement Mother (n=189, 158) 0.08  (5.40) -0.17  (5.41)
Child Involvement Father (n=188, 159) 0.38  (5.89) -0.15  (5.37)
Child Positive Parenting (n=188, 159) -0.80  (3.77) -0.24  (3.98)
Child Poor Supervision (n=188, 158) -1.12  (4.44) -1.23  (4.27)
Child Inconsistent Discipline (n=189,159) -0.60  (3.44) -0.81  (3.67)
Child Corporal Punishment (n=189, 160) -0.30  (1.78) -0.31  (1.66)
Child Other Discipline Practice (n=189, 159) -0.24  (3.71) -0.27  (3.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.895
Comments P-Value for Child Involvement Mother.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.792
Comments P-Value for Child Involvement Father.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.318
Comments P-Value for Child Positive Parenting.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments P-Value for Child Poor Supervision.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments P-Value for Child Inconsistent Discipline.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments P-Value for Child Corporal Punishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.827
Comments P-Value for Child Other Discipline Practice.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
20.Secondary Outcome
Title Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
Hide Description 42-item scale, 3 subscales (z-scores [-2 to 2]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.
Time Frame Baseline, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 189 160
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Child Involvement Mother (n=189, 159) 0.12  (5.94) -0.11  (5.41)
Child Involvement Father (n=188, 159) 0.36  (6.25) 0.44  (5.48)
Child Positive Parenting (n=188, 159) -0.90  (3.85) -0.33  (4.05)
Child Poor Supervision (n=188, 158) -1.52  (4.60) -1.31  (4.13)
Child Inconsistent Discipline (n=189, 159) -0.44  (3.61) -0.86  (3.73)
Child Corporal Punishment (n=189, 160) -0.25  (1.99) -0.34  (1.95)
Child Other Discipline Practice (n=189, 159) -0.24  (3.97) -0.19  (4.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.828
Comments P-Value for Child Involvement Mother.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments P-Value for Child Involvement Father.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments P-Value for Child Positive Parenting.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments P-Value for Child Poor Supervision.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.772
Comments P-Value for Child Inconsistent Discipline.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments P-Value for Child Corporal Punishment.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.636
Comments P-Value for Child Other Discipline Practice.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
21.Secondary Outcome
Title Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form
Hide Description Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: participants were included in the ITT population if they had a baseline and at least one post-baseline efficacy measurement. Last observation carried forward (LOCF) was used.
Arm/Group Title Atomoxetine Placebo
Hide Arm/Group Description:
Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
Overall Number of Participants Analyzed 181 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Total ADHD Score -2.93  (8.58) -2.57  (8.91)
Hyperactive-Impulsive Symptom ADHD Score -1.18  (4.43) -1.26  (4.48)
Inattention Symptom ADHD Score -1.75  (4.98) -1.30  (5.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.583
Comments P-Value for Total ADHD Score.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments P-Value for Hyperactive-Impulsive Symptom ADHD Score.
Method ANCOVA
Comments Model included treatment, pooled investigator, child with ADHD, and baseline.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.333
Comments P