Trial Outcomes & Findings for A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00190775)

NCT ID: NCT00190775

Last Updated: 2011-08-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

502 participants

Primary outcome timeframe

Baseline, 24 weeks

Results posted on

2011-08-22

Participant Flow

Participant milestones

Participant milestones
Measure	Atomoxetine 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 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 Study STARTED	268	234
Overall Study Received Study Drug	266	234
Overall Study COMPLETED	119	134
Overall Study NOT COMPLETED	149	100

Reasons for withdrawal

Reasons for withdrawal
Measure	Atomoxetine 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 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 Study Adverse Event	57	22
Overall Study Satisfactory Response	1	0
Overall Study Lack of Efficacy	28	32
Overall Study Lost to Follow-up	31	23
Overall Study Participant Moved	0	1
Overall Study Withdrawal by Subject	24	13
Overall Study Sponsor Decision	1	0
Overall Study Physician Decision	3	0
Overall Study Noncompliance	3	5
Overall Study Protocol Violation	0	1
Overall Study Exclusion Criteria Met	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine n=268 Participants 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 n=234 Participants 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 n=502 Participants Total of all reporting groups
Age Continuous	41.21 Years STANDARD_DEVIATION 6.89 • n=93 Participants	41.39 Years STANDARD_DEVIATION 7.49 • n=4 Participants	41.30 Years STANDARD_DEVIATION 7.17 • n=27 Participants
Sex: Female, Male Female	131 Participants n=93 Participants	132 Participants n=4 Participants	263 Participants n=27 Participants
Sex: Female, Male Male	137 Participants n=93 Participants	102 Participants n=4 Participants	239 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	24 Participants n=93 Participants	20 Participants n=4 Participants	44 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	227 Participants n=93 Participants	199 Participants n=4 Participants	426 Participants n=27 Participants
Race/Ethnicity, Customized African Descent	11 Participants n=93 Participants	6 Participants n=4 Participants	17 Participants n=27 Participants
Race/Ethnicity, Customized East/Southeast Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Western Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Other	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	255 Participants n=93 Participants	224 Participants n=4 Participants	479 Participants n=27 Participants
Region of Enrollment Puerto Rico	13 Participants n=93 Participants	10 Participants n=4 Participants	23 Participants n=27 Participants
Attention Deficit Hyperactivity Disorder (ADHD) Subtype Combined	179 Participants n=93 Participants	166 Participants n=4 Participants	345 Participants n=27 Participants
Attention Deficit Hyperactivity Disorder (ADHD) Subtype Inattentive	89 Participants n=93 Participants	67 Participants n=4 Participants	156 Participants n=27 Participants
Attention Deficit Hyperactivity Disorder (ADHD) Subtype Hyperactive/Impulsive	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Previous Stimulant Exposure Yes	47 Participants n=93 Participants	35 Participants n=4 Participants	82 Participants n=27 Participants
Previous Stimulant Exposure No	220 Participants n=93 Participants	198 Participants n=4 Participants	418 Participants n=27 Participants
Previous Stimulant Exposure Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) AISRS Total Score	36.07 Units on a scale STANDARD_DEVIATION 7.64 • n=93 Participants	36.59 Units on a scale STANDARD_DEVIATION 8.34 • n=4 Participants	36.31 Units on a scale STANDARD_DEVIATION 7.97 • n=27 Participants
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) AISRS Inattention Score	20.91 Units on a scale STANDARD_DEVIATION 3.83 • n=93 Participants	20.62 Units on a scale STANDARD_DEVIATION 4.02 • n=4 Participants	20.77 Units on a scale STANDARD_DEVIATION 3.92 • n=27 Participants
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) AISRS Hyperactivity Score	15.16 Units on a scale STANDARD_DEVIATION 5.75 • n=93 Participants	15.97 Units on a scale STANDARD_DEVIATION 5.94 • n=4 Participants	15.54 Units on a scale STANDARD_DEVIATION 5.85 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Involvement Mother	35.30 Units on a scale STANDARD_DEVIATION 6.02 • n=93 Participants	36.09 Units on a scale STANDARD_DEVIATION 5.90 • n=4 Participants	35.67 Units on a scale STANDARD_DEVIATION 5.97 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Involvement Father	31.50 Units on a scale STANDARD_DEVIATION 6.85 • n=93 Participants	32.35 Units on a scale STANDARD_DEVIATION 6.86 • n=4 Participants	31.90 Units on a scale STANDARD_DEVIATION 6.86 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Positive Parenting	23.85 Units on a scale STANDARD_DEVIATION 4.04 • n=93 Participants	23.40 Units on a scale STANDARD_DEVIATION 4.02 • n=4 Participants	23.64 Units on a scale STANDARD_DEVIATION 4.03 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Poor Monitoring/Supervision	16.93 Units on a scale STANDARD_DEVIATION 4.92 • n=93 Participants	17.27 Units on a scale STANDARD_DEVIATION 5.34 • n=4 Participants	17.09 Units on a scale STANDARD_DEVIATION 5.12 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Inconsistent Discipline	12.66 Units on a scale STANDARD_DEVIATION 3.44 • n=93 Participants	13.01 Units on a scale STANDARD_DEVIATION 3.57 • n=4 Participants	12.83 Units on a scale STANDARD_DEVIATION 3.50 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Corporal Punishment	4.86 Units on a scale STANDARD_DEVIATION 2.08 • n=93 Participants	4.99 Units on a scale STANDARD_DEVIATION 2.37 • n=4 Participants	4.92 Units on a scale STANDARD_DEVIATION 2.22 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Child Other Discipline Practice	17.62 Units on a scale STANDARD_DEVIATION 3.52 • n=93 Participants	18.18 Units on a scale STANDARD_DEVIATION 3.88 • n=4 Participants	17.88 Units on a scale STANDARD_DEVIATION 3.70 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Involvement	37.71 Units on a scale STANDARD_DEVIATION 5.11 • n=93 Participants	37.61 Units on a scale STANDARD_DEVIATION 5.62 • n=4 Participants	37.67 Units on a scale STANDARD_DEVIATION 5.34 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Positive Parenting	-0.00 Units on a scale STANDARD_DEVIATION 0.95 • n=93 Participants	-0.07 Units on a scale STANDARD_DEVIATION 1.05 • n=4 Participants	-0.04 Units on a scale STANDARD_DEVIATION 1.00 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Poor Monitoring Supervision	16.64 Units on a scale STANDARD_DEVIATION 4.91 • n=93 Participants	16.50 Units on a scale STANDARD_DEVIATION 4.78 • n=4 Participants	16.58 Units on a scale STANDARD_DEVIATION 4.85 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Inconsistent Discipline	15.37 Units on a scale STANDARD_DEVIATION 3.44 • n=93 Participants	15.48 Units on a scale STANDARD_DEVIATION 3.42 • n=4 Participants	15.42 Units on a scale STANDARD_DEVIATION 3.42 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Corporal Punishment	4.73 Units on a scale STANDARD_DEVIATION 1.60 • n=93 Participants	4.75 Units on a scale STANDARD_DEVIATION 1.76 • n=4 Participants	4.74 Units on a scale STANDARD_DEVIATION 1.67 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Other Discipline Practice	19.53 Units on a scale STANDARD_DEVIATION 3.08 • n=93 Participants	19.64 Units on a scale STANDARD_DEVIATION 2.96 • n=4 Participants	19.58 Units on a scale STANDARD_DEVIATION 3.02 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Dysfunctional Parenting Composite	0.12 Units on a scale STANDARD_DEVIATION 0.98 • n=93 Participants	0.17 Units on a scale STANDARD_DEVIATION 1.01 • n=4 Participants	0.14 Units on a scale STANDARD_DEVIATION 0.99 • n=27 Participants
Alabama Parenting Questionnaire (APQ) Parent Negative Parenting	0.21 Units on a scale STANDARD_DEVIATION 1.05 • n=93 Participants	0.21 Units on a scale STANDARD_DEVIATION 0.99 • n=4 Participants	0.21 Units on a scale STANDARD_DEVIATION 1.02 • n=27 Participants
Body Mass Index (BMI)	30.15 Kilograms/square meters STANDARD_DEVIATION 6.58 • n=93 Participants	29.31 Kilograms/square meters STANDARD_DEVIATION 6.51 • n=4 Participants	29.76 Kilograms/square meters STANDARD_DEVIATION 6.56 • n=27 Participants
Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Total Score	24.56 Units on a scale STANDARD_DEVIATION 13.30 • n=93 Participants	24.35 Units on a scale STANDARD_DEVIATION 13.01 • n=4 Participants	24.46 Units on a scale STANDARD_DEVIATION 13.16 • n=27 Participants
Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Inattention Symptom ADHD Score	13.39 Units on a scale STANDARD_DEVIATION 7.30 • n=93 Participants	13.35 Units on a scale STANDARD_DEVIATION 6.86 • n=4 Participants	13.37 Units on a scale STANDARD_DEVIATION 7.09 • n=27 Participants
Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Hyperactive-Impulsive Symptom ADHD Score	11.17 Units on a scale STANDARD_DEVIATION 6.98 • n=93 Participants	11.00 Units on a scale STANDARD_DEVIATION 6.95 • n=4 Participants	11.09 Units on a scale STANDARD_DEVIATION 6.96 • n=27 Participants
Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)	4.56 Units on a scale STANDARD_DEVIATION 0.62 • n=93 Participants	4.58 Units on a scale STANDARD_DEVIATION 0.60 • n=4 Participants	4.57 Units on a scale STANDARD_DEVIATION 0.61 • n=27 Participants
Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score	34.64 Units on a scale STANDARD_DEVIATION 8.39 • n=93 Participants	35.50 Units on a scale STANDARD_DEVIATION 8.53 • n=4 Participants	35.04 Units on a scale STANDARD_DEVIATION 8.46 • n=27 Participants
Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Inattention Subscale	19.97 Units on a scale STANDARD_DEVIATION 4.45 • n=93 Participants	19.90 Units on a scale STANDARD_DEVIATION 4.33 • n=4 Participants	19.94 Units on a scale STANDARD_DEVIATION 4.39 • n=27 Participants
Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Hyper/Impulsive Subscale	14.67 Units on a scale STANDARD_DEVIATION 5.89 • n=93 Participants	15.60 Units on a scale STANDARD_DEVIATION 5.80 • n=4 Participants	15.11 Units on a scale STANDARD_DEVIATION 5.86 • n=27 Participants
Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Index Subscale	21.60 Units on a scale STANDARD_DEVIATION 5.37 • n=93 Participants	21.49 Units on a scale STANDARD_DEVIATION 5.74 • n=4 Participants	21.55 Units on a scale STANDARD_DEVIATION 5.54 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Participant (Self) Total Dyadic Adjustment	43.06 T-scores of units on a scale STANDARD_DEVIATION 11.90 • n=93 Participants	42.37 T-scores of units on a scale STANDARD_DEVIATION 11.11 • n=4 Participants	42.74 T-scores of units on a scale STANDARD_DEVIATION 11.53 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Participant (Self) Affectional Expression	43.70 T-scores of units on a scale STANDARD_DEVIATION 12.52 • n=93 Participants	44.85 T-scores of units on a scale STANDARD_DEVIATION 11.68 • n=4 Participants	44.24 T-scores of units on a scale STANDARD_DEVIATION 12.14 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Participant (Self) Dyadic Cohesion	52.51 T-scores of units on a scale STANDARD_DEVIATION 10.63 • n=93 Participants	51.58 T-scores of units on a scale STANDARD_DEVIATION 10.02 • n=4 Participants	52.08 T-scores of units on a scale STANDARD_DEVIATION 10.35 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Participant (Self) Dyadic Consensus	44.99 T-scores of units on a scale STANDARD_DEVIATION 9.22 • n=93 Participants	44.26 T-scores of units on a scale STANDARD_DEVIATION 8.69 • n=4 Participants	44.65 T-scores of units on a scale STANDARD_DEVIATION 8.98 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Participant (Self) Dyadic Satisfaction	42.98 T-scores of units on a scale STANDARD_DEVIATION 10.82 • n=93 Participants	42.49 T-scores of units on a scale STANDARD_DEVIATION 10.24 • n=4 Participants	42.75 T-scores of units on a scale STANDARD_DEVIATION 10.55 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Total Dyadic Adjustment	41.93 T-scores of units on a scale STANDARD_DEVIATION 11.44 • n=93 Participants	41.75 T-scores of units on a scale STANDARD_DEVIATION 11.29 • n=4 Participants	41.85 T-scores of units on a scale STANDARD_DEVIATION 11.36 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Affectational Expression	43.18 T-scores of units on a scale STANDARD_DEVIATION 11.97 • n=93 Participants	43.66 T-scores of units on a scale STANDARD_DEVIATION 12.28 • n=4 Participants	43.41 T-scores of units on a scale STANDARD_DEVIATION 12.10 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Cohesion	51.35 T-scores of units on a scale STANDARD_DEVIATION 11.09 • n=93 Participants	51.70 T-scores of units on a scale STANDARD_DEVIATION 10.30 • n=4 Participants	51.51 T-scores of units on a scale STANDARD_DEVIATION 10.72 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Consensus	40.82 T-scores of units on a scale STANDARD_DEVIATION 10.18 • n=93 Participants	40.44 T-scores of units on a scale STANDARD_DEVIATION 10.02 • n=4 Participants	40.64 T-scores of units on a scale STANDARD_DEVIATION 10.10 • n=27 Participants
Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Satisfaction	42.25 T-scores of units on a scale STANDARD_DEVIATION 10.75 • n=93 Participants	41.84 T-scores of units on a scale STANDARD_DEVIATION 10.53 • n=4 Participants	42.06 T-scores of units on a scale STANDARD_DEVIATION 10.64 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Task Accomplishment	62.78 T-scores of units on a scale STANDARD_DEVIATION 5.56 • n=93 Participants	62.38 T-scores of units on a scale STANDARD_DEVIATION 5.43 • n=4 Participants	62.59 T-scores of units on a scale STANDARD_DEVIATION 5.50 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Role Performance	60.81 T-scores of units on a scale STANDARD_DEVIATION 5.03 • n=93 Participants	61.13 T-scores of units on a scale STANDARD_DEVIATION 5.75 • n=4 Participants	60.96 T-scores of units on a scale STANDARD_DEVIATION 5.37 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Communication	64.97 T-scores of units on a scale STANDARD_DEVIATION 6.49 • n=93 Participants	64.24 T-scores of units on a scale STANDARD_DEVIATION 6.35 • n=4 Participants	64.63 T-scores of units on a scale STANDARD_DEVIATION 6.43 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Affective Expression	61.48 T-scores of units on a scale STANDARD_DEVIATION 8.63 • n=93 Participants	61.71 T-scores of units on a scale STANDARD_DEVIATION 9.47 • n=4 Participants	61.59 T-scores of units on a scale STANDARD_DEVIATION 9.02 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Involvement	64.07 T-scores of units on a scale STANDARD_DEVIATION 7.92 • n=93 Participants	64.59 T-scores of units on a scale STANDARD_DEVIATION 7.35 • n=4 Participants	64.31 T-scores of units on a scale STANDARD_DEVIATION 7.66 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Control	62.70 T-scores of units on a scale STANDARD_DEVIATION 5.95 • n=93 Participants	62.13 T-scores of units on a scale STANDARD_DEVIATION 6.07 • n=4 Participants	62.43 T-scores of units on a scale STANDARD_DEVIATION 6.01 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Values and Norms	65.66 T-scores of units on a scale STANDARD_DEVIATION 6.70 • n=93 Participants	64.90 T-scores of units on a scale STANDARD_DEVIATION 7.44 • n=4 Participants	65.30 T-scores of units on a scale STANDARD_DEVIATION 7.06 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Task Accomplishment	61.52 T-scores of units on a scale STANDARD_DEVIATION 5.97 • n=93 Participants	60.90 T-scores of units on a scale STANDARD_DEVIATION 5.83 • n=4 Participants	61.23 T-scores of units on a scale STANDARD_DEVIATION 5.91 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Role Performance	61.28 T-scores of units on a scale STANDARD_DEVIATION 5.67 • n=93 Participants	60.59 T-scores of units on a scale STANDARD_DEVIATION 6.00 • n=4 Participants	60.96 T-scores of units on a scale STANDARD_DEVIATION 5.83 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Communication	64.05 T-scores of units on a scale STANDARD_DEVIATION 6.37 • n=93 Participants	63.47 T-scores of units on a scale STANDARD_DEVIATION 7.02 • n=4 Participants	63.78 T-scores of units on a scale STANDARD_DEVIATION 6.68 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Affective Expression	61.97 T-scores of units on a scale STANDARD_DEVIATION 9.67 • n=93 Participants	61.68 T-scores of units on a scale STANDARD_DEVIATION 9.07 • n=4 Participants	61.84 T-scores of units on a scale STANDARD_DEVIATION 9.39 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Involvement	64.96 T-scores of units on a scale STANDARD_DEVIATION 8.95 • n=93 Participants	64.52 T-scores of units on a scale STANDARD_DEVIATION 8.77 • n=4 Participants	64.76 T-scores of units on a scale STANDARD_DEVIATION 8.86 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Control	61.98 T-scores of units on a scale STANDARD_DEVIATION 6.52 • n=93 Participants	61.34 T-scores of units on a scale STANDARD_DEVIATION 6.25 • n=4 Participants	61.68 T-scores of units on a scale STANDARD_DEVIATION 6.40 • n=27 Participants
Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Values and Norms	65.32 T-scores of units on a scale STANDARD_DEVIATION 7.11 • n=93 Participants	65.52 T-scores of units on a scale STANDARD_DEVIATION 7.17 • n=4 Participants	65.41 T-scores of units on a scale STANDARD_DEVIATION 7.13 • n=27 Participants
Height	171.23 Centimeters STANDARD_DEVIATION 10.37 • n=93 Participants	170.01 Centimeters STANDARD_DEVIATION 9.74 • n=4 Participants	170.66 Centimeters STANDARD_DEVIATION 10.09 • n=27 Participants
Montgomery-Asberg Depression Rating Scale Total Score (MADRS)	8.13 Units on a scale STANDARD_DEVIATION 4.80 • n=93 Participants	8.12 Units on a scale STANDARD_DEVIATION 5.01 • n=4 Participants	8.13 Units on a scale STANDARD_DEVIATION 4.89 • n=27 Participants
Parent Stress Index (PSI) Total Stress and Life Stress Total Stress	285.40 Units on a scale STANDARD_DEVIATION 53.45 • n=93 Participants	277.11 Units on a scale STANDARD_DEVIATION 52.65 • n=4 Participants	281.53 Units on a scale STANDARD_DEVIATION 53.18 • n=27 Participants
Parent Stress Index (PSI) Total Stress and Life Stress Life Stress	1.57 Units on a scale STANDARD_DEVIATION 3.56 • n=93 Participants	1.76 Units on a scale STANDARD_DEVIATION 3.68 • n=4 Participants	1.66 Units on a scale STANDARD_DEVIATION 3.62 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Total	135.40 Units on a scale STANDARD_DEVIATION 25.22 • n=93 Participants	130.22 Units on a scale STANDARD_DEVIATION 24.62 • n=4 Participants	132.98 Units on a scale STANDARD_DEVIATION 25.05 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Role Restriction	18.93 Units on a scale STANDARD_DEVIATION 5.33 • n=93 Participants	18.26 Units on a scale STANDARD_DEVIATION 4.99 • n=4 Participants	18.62 Units on a scale STANDARD_DEVIATION 5.18 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Depression	22.79 Units on a scale STANDARD_DEVIATION 6.10 • n=93 Participants	21.01 Units on a scale STANDARD_DEVIATION 5.68 • n=4 Participants	21.96 Units on a scale STANDARD_DEVIATION 5.97 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Spouse	18.19 Units on a scale STANDARD_DEVIATION 5.03 • n=93 Participants	18.14 Units on a scale STANDARD_DEVIATION 5.04 • n=4 Participants	18.17 Units on a scale STANDARD_DEVIATION 5.03 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Competence	32.63 Units on a scale STANDARD_DEVIATION 6.69 • n=93 Participants	31.78 Units on a scale STANDARD_DEVIATION 7.10 • n=4 Participants	32.23 Units on a scale STANDARD_DEVIATION 6.89 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Isolation	15.49 Units on a scale STANDARD_DEVIATION 4.71 • n=93 Participants	14.56 Units on a scale STANDARD_DEVIATION 4.61 • n=4 Participants	15.06 Units on a scale STANDARD_DEVIATION 4.68 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Attachment	13.74 Units on a scale STANDARD_DEVIATION 4.21 • n=93 Participants	12.95 Units on a scale STANDARD_DEVIATION 3.61 • n=4 Participants	13.37 Units on a scale STANDARD_DEVIATION 3.96 • n=27 Participants
Parent Stress Index (PSI) Parent Domains Parent Domain Health	13.72 Units on a scale STANDARD_DEVIATION 2.71 • n=93 Participants	13.52 Units on a scale STANDARD_DEVIATION 2.62 • n=4 Participants	13.63 Units on a scale STANDARD_DEVIATION 2.67 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Total	150.00 Units on a scale STANDARD_DEVIATION 34.46 • n=93 Participants	146.88 Units on a scale STANDARD_DEVIATION 34.44 • n=4 Participants	148.54 Units on a scale STANDARD_DEVIATION 34.45 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Distractibility/Hyperactivity	27.49 Units on a scale STANDARD_DEVIATION 6.46 • n=93 Participants	27.59 Units on a scale STANDARD_DEVIATION 6.48 • n=4 Participants	27.54 Units on a scale STANDARD_DEVIATION 6.47 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Adaptability	48.29 Units on a scale STANDARD_DEVIATION 11.56 • n=93 Participants	47.59 Units on a scale STANDARD_DEVIATION 12.28 • n=4 Participants	47.96 Units on a scale STANDARD_DEVIATION 11.89 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Reinforces Parent	24.87 Units on a scale STANDARD_DEVIATION 7.13 • n=93 Participants	23.75 Units on a scale STANDARD_DEVIATION 7.07 • n=4 Participants	24.34 Units on a scale STANDARD_DEVIATION 7.12 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Demandingness	20.99 Units on a scale STANDARD_DEVIATION 6.09 • n=93 Participants	20.71 Units on a scale STANDARD_DEVIATION 6.48 • n=4 Participants	20.85 Units on a scale STANDARD_DEVIATION 6.27 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Mood	12.42 Units on a scale STANDARD_DEVIATION 3.89 • n=93 Participants	12.06 Units on a scale STANDARD_DEVIATION 4.03 • n=4 Participants	12.25 Units on a scale STANDARD_DEVIATION 3.96 • n=27 Participants
Parent Stress Index (PSI) Child Domains Child Domain Acceptability	15.94 Units on a scale STANDARD_DEVIATION 4.75 • n=93 Participants	15.18 Units on a scale STANDARD_DEVIATION 4.67 • n=4 Participants	15.59 Units on a scale STANDARD_DEVIATION 4.72 • n=27 Participants
Parenting Sense of Competence (PSOC) Scale Total	58.64 Units on a scale STANDARD_DEVIATION 9.83 • n=93 Participants	60.80 Units on a scale STANDARD_DEVIATION 9.18 • n=4 Participants	59.65 Units on a scale STANDARD_DEVIATION 9.58 • n=27 Participants
Parenting Sense of Competence (PSOC) Scale Satisfaction Scale	33.46 Units on a scale STANDARD_DEVIATION 6.58 • n=93 Participants	34.94 Units on a scale STANDARD_DEVIATION 6.38 • n=4 Participants	34.15 Units on a scale STANDARD_DEVIATION 6.52 • n=27 Participants
Parenting Sense of Competence (PSOC) Scale Efficacy Scale	25.18 Units on a scale STANDARD_DEVIATION 4.72 • n=93 Participants	25.86 Units on a scale STANDARD_DEVIATION 4.31 • n=4 Participants	25.50 Units on a scale STANDARD_DEVIATION 4.54 • n=27 Participants
State-Trait Anxiety Inventories (STAI) State Anxiety Score	40.13 Units on a scale STANDARD_DEVIATION 11.55 • n=93 Participants	41.16 Units on a scale STANDARD_DEVIATION 11.18 • n=4 Participants	40.61 Units on a scale STANDARD_DEVIATION 11.38 • n=27 Participants
State-Trait Anxiety Inventories (STAI) Trait Anxiety Score	47.44 Units on a scale STANDARD_DEVIATION 10.68 • n=93 Participants	46.05 Units on a scale STANDARD_DEVIATION 11.22 • n=4 Participants	46.79 Units on a scale STANDARD_DEVIATION 10.94 • n=27 Participants
Weight	88.22 Kilograms STANDARD_DEVIATION 20.40 • n=93 Participants	84.84 Kilograms STANDARD_DEVIATION 19.72 • n=4 Participants	86.65 Kilograms STANDARD_DEVIATION 20.14 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.

Outcome measures

Outcome measures
Measure	Atomoxetine n=125 Participants 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 n=136 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
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	-16.43 Units on a scale Standard Error 0.88	-8.65 Units on a scale Standard Error 0.85	—

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=180 Participants 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 n=165 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
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	-14.33 Units on a scale Standard Error 0.83	-10.05 Units on a scale Standard Error 0.82	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Task Accomplishment	-0.79 T-scores of units on a scale Standard Deviation 6.66	-0.41 T-scores of units on a scale Standard Deviation 6.37	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Role Performance	-0.25 T-scores of units on a scale Standard Deviation 5.30	-0.04 T-scores of units on a scale Standard Deviation 6.18	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Communication	-0.63 T-scores of units on a scale Standard Deviation 7.50	-0.29 T-scores of units on a scale Standard Deviation 6.88	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Affective Expression	0.50 T-scores of units on a scale Standard Deviation 7.75	-0.33 T-scores of units on a scale Standard Deviation 7.86	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Involvement	-0.27 T-scores of units on a scale Standard Deviation 7.79	0.17 T-scores of units on a scale Standard Deviation 7.54	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Control	-0.01 T-scores of units on a scale Standard Deviation 6.64	0.33 T-scores of units on a scale Standard Deviation 6.56	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Values and Norms	0.00 T-scores of units on a scale Standard Deviation 6.97	-0.27 T-scores of units on a scale Standard Deviation 8.02	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Role Performance	-0.33 T-scores of units on a scale Standard Deviation 5.60	0.27 T-scores of units on a scale Standard Deviation 6.65	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Communication	-1.15 T-scores of units on a scale Standard Deviation 7.49	-0.58 T-scores of units on a scale Standard Deviation 6.73	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Task Accomplishment	-0.81 T-scores of units on a scale Standard Deviation 6.45	-0.90 T-scores of units on a scale Standard Deviation 6.59	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Affective Expression	0.05 T-scores of units on a scale Standard Deviation 8.31	0.25 T-scores of units on a scale Standard Deviation 8.10	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Involvement	-0.32 T-scores of units on a scale Standard Deviation 7.68	0.56 T-scores of units on a scale Standard Deviation 7.32	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Control	-0.53 T-scores of units on a scale Standard Deviation 6.89	0.41 T-scores of units on a scale Standard Deviation 6.21	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant Values and Norms	-0.67 T-scores of units on a scale Standard Deviation 7.15	0.31 T-scores of units on a scale Standard Deviation 8.21	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Task Accomplishment	-0.28 T-scores of units on a scale Standard Deviation 6.57	0.15 T-scores of units on a scale Standard Deviation 7.10	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Role Performance	-0.86 T-scores of units on a scale Standard Deviation 5.86	-0.35 T-scores of units on a scale Standard Deviation 6.33	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Communication	-0.15 T-scores of units on a scale Standard Deviation 7.24	-0.05 T-scores of units on a scale Standard Deviation 7.21	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Affective Expression	0.17 T-scores of units on a scale Standard Deviation 8.30	0.32 T-scores of units on a scale Standard Deviation 8.83	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Involvement	-0.25 T-scores of units on a scale Standard Deviation 7.50	0.11 T-scores of units on a scale Standard Deviation 7.81	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Control	0.15 T-scores of units on a scale Standard Deviation 6.46	0.54 T-scores of units on a scale Standard Deviation 6.78	—
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Values and Norms	-0.27 T-scores of units on a scale Standard Deviation 8.15	-0.95 T-scores of units on a scale Standard Deviation 7.08	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Involvement	-0.47 T-scores of units on a scale Standard Deviation 7.88	-0.10 T-scores of units on a scale Standard Deviation 7.69	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Control	0.05 T-scores of units on a scale Standard Deviation 7.15	0.73 T-scores of units on a scale Standard Deviation 6.69	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Task Accomplishment	-0.79 T-scores of units on a scale Standard Deviation 6.94	0.24 T-scores of units on a scale Standard Deviation 6.99	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Role Performance	-0.93 T-scores of units on a scale Standard Deviation 6.03	-0.41 T-scores of units on a scale Standard Deviation 6.37	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Communication	0.14 T-scores of units on a scale Standard Deviation 7.09	-0.09 T-scores of units on a scale Standard Deviation 7.17	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Affective Expression	-0.08 T-scores of units on a scale Standard Deviation 8.02	0.60 T-scores of units on a scale Standard Deviation 8.79	—
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Values and Norms	-0.19 T-scores of units on a scale Standard Deviation 8.00	-0.57 T-scores of units on a scale Standard Deviation 7.34	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Total Dyadic Adjustment	1.13 T-scores of units on a scale Standard Deviation 6.33	0.70 T-scores of units on a scale Standard Deviation 6.55	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Dyadic Consensus	1.61 T-scores of units on a scale Standard Deviation 6.77	1.42 T-scores of units on a scale Standard Deviation 7.22	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Dyadic Satisfaction	0.52 T-scores of units on a scale Standard Deviation 6.22	-0.02 T-scores of units on a scale Standard Deviation 5.53	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Affectional Expression	1.16 T-scores of units on a scale Standard Deviation 9.00	-0.85 T-scores of units on a scale Standard Deviation 8.27	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Dyadic Cohesion	-0.06 T-scores of units on a scale Standard Deviation 7.65	0.54 T-scores of units on a scale Standard Deviation 6.86	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Total Dyadic Adjustment	1.21 T-scores of units on a scale Standard Deviation 7.12	0.51 T-scores of units on a scale Standard Deviation 7.74	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Dyadic Consensus	2.13 T-scores of units on a scale Standard Deviation 6.97	1.58 T-scores of units on a scale Standard Deviation 8.34	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Dyadic Satisfaction	0.47 T-scores of units on a scale Standard Deviation 6.83	-0.32 T-scores of units on a scale Standard Deviation 6.13	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Affectional Expression	0.62 T-scores of units on a scale Standard Deviation 9.09	-1.13 T-scores of units on a scale Standard Deviation 9.93	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant Dyadic Cohesion	0.30 T-scores of units on a scale Standard Deviation 7.92	0.16 T-scores of units on a scale Standard Deviation 8.01	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=246 Participants 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 n=215 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Total Dyadic Adjustment	2.09 T-scores of units on a scale Standard Deviation 6.37	2.64 T-scores of units on a scale Standard Deviation 7.13	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Consensus	2.49 T-scores of units on a scale Standard Deviation 6.84	3.67 T-scores of units on a scale Standard Deviation 7.92	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Satisfaction	1.37 T-scores of units on a scale Standard Deviation 5.81	1.61 T-scores of units on a scale Standard Deviation 6.36	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Affectional Expression	1.57 T-scores of units on a scale Standard Deviation 9.40	1.23 T-scores of units on a scale Standard Deviation 9.57	—
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Cohesion	0.81 T-scores of units on a scale Standard Deviation 7.33	0.29 T-scores of units on a scale Standard Deviation 8.23	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=246 Participants 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 n=215 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Affectional Expression	1.38 T-scores of units on a scale Standard Deviation 10.08	2.00 T-scores of units on a scale Standard Deviation 8.00	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Total Dyadic Adjustment	2.09 T-scores of units on a scale Standard Deviation 6.97	2.84 T-scores of units on a scale Standard Deviation 6.80	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Consensus	2.79 T-scores of units on a scale Standard Deviation 7.49	3.87 T-scores of units on a scale Standard Deviation 7.22	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Satisfaction	1.32 T-scores of units on a scale Standard Deviation 6.17	1.27 T-scores of units on a scale Standard Deviation 6.47	—
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Cohesion	0.87 T-scores of units on a scale Standard Deviation 7.70	0.99 T-scores of units on a scale Standard Deviation 7.60	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress Total Stress	-10.74 Units on a scale Standard Deviation 32.14	-7.06 Units on a scale Standard Deviation 26.63	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress Life Stress	0.25 Units on a scale Standard Deviation 4.22	-0.30 Units on a scale Standard Deviation 4.04	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Total	-5.08 Units on a scale Standard Deviation 17.40	-1.34 Units on a scale Standard Deviation 12.95	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Competence	-1.78 Units on a scale Standard Deviation 5.29	-1.24 Units on a scale Standard Deviation 4.26	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Isolation	-0.68 Units on a scale Standard Deviation 3.55	-0.11 Units on a scale Standard Deviation 2.97	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Attachment	0.05 Units on a scale Standard Deviation 3.34	0.40 Units on a scale Standard Deviation 2.74	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Health	0.05 Units on a scale Standard Deviation 2.48	-0.05 Units on a scale Standard Deviation 2.18	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Role Restriction	-0.51 Units on a scale Standard Deviation 4.07	0.06 Units on a scale Standard Deviation 3.75	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Depression	-1.55 Units on a scale Standard Deviation 4.70	-0.08 Units on a scale Standard Deviation 3.78	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Spouse	-0.74 Units on a scale Standard Deviation 3.63	-0.32 Units on a scale Standard Deviation 3.72	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Demandingness	-0.56 Units on a scale Standard Deviation 3.78	-1.00 Units on a scale Standard Deviation 3.99	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Acceptability	-0.68 Units on a scale Standard Deviation 3.48	-0.34 Units on a scale Standard Deviation 3.31	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Total	-5.66 Units on a scale Standard Deviation 19.12	-5.72 Units on a scale Standard Deviation 18.62	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Defensive Responding	-1.66 Units on a scale Standard Deviation 5.48	-0.35 Units on a scale Standard Deviation 4.75	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Distractibility/Hyperactive	-1.70 Units on a scale Standard Deviation 4.15	-1.93 Units on a scale Standard Deviation 4.11	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Adaptability	-1.56 Units on a scale Standard Deviation 6.92	-1.87 Units on a scale Standard Deviation 7.23	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Reinforces Parent	-0.79 Units on a scale Standard Deviation 4.98	-0.32 Units on a scale Standard Deviation 4.44	—
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Mood	-0.36 Units on a scale Standard Deviation 2.63	-0.26 Units on a scale Standard Deviation 2.67	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress Total Stress	-17.19 Units on a scale Standard Deviation 40.19	-10.97 Units on a scale Standard Deviation 31.33	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress Life Stress	0.99 Units on a scale Standard Deviation 4.91	0.19 Units on a scale Standard Deviation 4.93	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Health	-0.09 Units on a scale Standard Deviation 2.75	0.07 Units on a scale Standard Deviation 2.45	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Role Restriction	-0.52 Units on a scale Standard Deviation 4.58	-0.31 Units on a scale Standard Deviation 4.00	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Total	-7.66 Units on a scale Standard Deviation 21.45	-3.12 Units on a scale Standard Deviation 15.18	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Competence	-2.58 Units on a scale Standard Deviation 5.77	-1.57 Units on a scale Standard Deviation 4.54	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Isolation	-1.08 Units on a scale Standard Deviation 3.61	-0.28 Units on a scale Standard Deviation 3.17	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Attachment	-0.19 Units on a scale Standard Deviation 3.53	-0.01 Units on a scale Standard Deviation 2.57	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Depression	-2.13 Units on a scale Standard Deviation 5.29	-0.54 Units on a scale Standard Deviation 4.29	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains Parent Domain Spouse	-0.75 Units on a scale Standard Deviation 4.22	-0.48 Units on a scale Standard Deviation 3.70	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=262 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Adaptability	-2.66 Units on a scale Standard Deviation 7.95	-2.44 Units on a scale Standard Deviation 7.28	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Reinforces Parent	-1.54 Units on a scale Standard Deviation 5.58	-0.63 Units on a scale Standard Deviation 4.96	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Total	-9.52 Units on a scale Standard Deviation 22.92	-7.85 Units on a scale Standard Deviation 20.07	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Defensive Responding	-2.28 Units on a scale Standard Deviation 6.44	-0.84 Units on a scale Standard Deviation 5.20	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Distractibility/Hyperactive	-2.28 Units on a scale Standard Deviation 4.24	-2.60 Units on a scale Standard Deviation 4.35	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Demandingness	-1.06 Units on a scale Standard Deviation 4.14	-1.30 Units on a scale Standard Deviation 4.19	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Mood	-0.72 Units on a scale Standard Deviation 2.89	-0.33 Units on a scale Standard Deviation 3.02	—
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains Child Domain Acceptability	-0.91 Units on a scale Standard Deviation 3.75	-0.56 Units on a scale Standard Deviation 3.51	—

SECONDARY outcome

Timeframe: Baseline, 12 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=230 Participants 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 n=192 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Involvement (n=230, 192)	0.27 Units on a scale Standard Deviation 3.96	0.67 Units on a scale Standard Deviation 3.57	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Positive Parenting (n=230, 192)	0.00 Units on a scale Standard Deviation 2.59	0.36 Units on a scale Standard Deviation 2.33	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Poor Supervision (n=229, 191)	-1.29 Units on a scale Standard Deviation 3.39	-1.17 Units on a scale Standard Deviation 3.43	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Inconsistent Discipline (n=230, 192)	-1.07 Units on a scale Standard Deviation 2.78	-0.81 Units on a scale Standard Deviation 2.59	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Corporal Punishment (n=230, 192)	-0.23 Units on a scale Standard Deviation 1.36	-0.21 Units on a scale Standard Deviation 1.00	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Other Discipline Practice (n=230, 190)	-0.01 Units on a scale Standard Deviation 2.51	0.00 Units on a scale Standard Deviation 2.57	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Dysfunctional Parenting Composite (n=229, 191)	-0.23 Units on a scale Standard Deviation 0.77	-0.26 Units on a scale Standard Deviation 0.65	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Negative Parenting Composite (n=229, 191)	-0.37 Units on a scale Standard Deviation 0.79	-0.32 Units on a scale Standard Deviation 0.74	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Positive Parenting Composite (n=230, 192)	0.03 Units on a scale Standard Deviation 0.72	0.13 Units on a scale Standard Deviation 0.64	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=230 Participants 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 n=292 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Involvement (n=230, 192)	0.31 Units on a scale Standard Deviation 3.84	0.43 Units on a scale Standard Deviation 3.47	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Positive Parenting (n=230, 192)	0.07 Units on a scale Standard Deviation 2.83	0.11 Units on a scale Standard Deviation 2.35	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Poor Supervision (n=229, 191)	-1.24 Units on a scale Standard Deviation 3.89	-0.96 Units on a scale Standard Deviation 3.31	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Inconsistent Discipline (n=230, 192)	-1.19 Units on a scale Standard Deviation 2.94	-0.82 Units on a scale Standard Deviation 2.75	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Parent Corporal Punishment (n=230, 192)	-0.25 Units on a scale Standard Deviation 1.34	-0.14 Units on a scale Standard Deviation 1.17	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Other Discipline Practice (n=230, 190)	0.22 Units on a scale Standard Deviation 2.67	0.18 Units on a scale Standard Deviation 2.27	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Dysfunctional Parenting Composite (n=229, 191)	-0.25 Units on a scale Standard Deviation 0.80	-0.20 Units on a scale Standard Deviation 0.56	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Negative Parenting Composite (n=229, 191)	-0.39 Units on a scale Standard Deviation 0.86	-0.28 Units on a scale Standard Deviation 0.71	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form Positive Parenting Composite (n=230, 192)	0.05 Units on a scale Standard Deviation 0.74	0.07 Units on a scale Standard Deviation 0.61	—

SECONDARY outcome

Timeframe: Baseline, 12 Weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=189 Participants 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 n=159 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Involvement Mother (n=189, 158)	0.08 Units on a scale Standard Deviation 5.40	-0.17 Units on a scale Standard Deviation 5.41	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Involvement Father (n=188, 159)	0.38 Units on a scale Standard Deviation 5.89	-0.15 Units on a scale Standard Deviation 5.37	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Positive Parenting (n=188, 159)	-0.80 Units on a scale Standard Deviation 3.77	-0.24 Units on a scale Standard Deviation 3.98	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Poor Supervision (n=188, 158)	-1.12 Units on a scale Standard Deviation 4.44	-1.23 Units on a scale Standard Deviation 4.27	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Inconsistent Discipline (n=189,159)	-0.60 Units on a scale Standard Deviation 3.44	-0.81 Units on a scale Standard Deviation 3.67	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Corporal Punishment (n=189, 160)	-0.30 Units on a scale Standard Deviation 1.78	-0.31 Units on a scale Standard Deviation 1.66	—
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Other Discipline Practice (n=189, 159)	-0.24 Units on a scale Standard Deviation 3.71	-0.27 Units on a scale Standard Deviation 3.77	—

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=189 Participants 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 n=160 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Involvement Mother (n=189, 159)	0.12 Units on a scale Standard Deviation 5.94	-0.11 Units on a scale Standard Deviation 5.41	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Involvement Father (n=188, 159)	0.36 Units on a scale Standard Deviation 6.25	0.44 Units on a scale Standard Deviation 5.48	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Positive Parenting (n=188, 159)	-0.90 Units on a scale Standard Deviation 3.85	-0.33 Units on a scale Standard Deviation 4.05	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Poor Supervision (n=188, 158)	-1.52 Units on a scale Standard Deviation 4.60	-1.31 Units on a scale Standard Deviation 4.13	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Inconsistent Discipline (n=189, 159)	-0.44 Units on a scale Standard Deviation 3.61	-0.86 Units on a scale Standard Deviation 3.73	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Corporal Punishment (n=189, 160)	-0.25 Units on a scale Standard Deviation 1.99	-0.34 Units on a scale Standard Deviation 1.95	—
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form Child Other Discipline Practice (n=189, 159)	-0.24 Units on a scale Standard Deviation 3.97	-0.19 Units on a scale Standard Deviation 4.02	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=181 Participants 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 n=159 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Total ADHD Score	-2.93 Units on a scale Standard Deviation 8.58	-2.57 Units on a scale Standard Deviation 8.91	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Hyperactive-Impulsive Symptom ADHD Score	-1.18 Units on a scale Standard Deviation 4.43	-1.26 Units on a scale Standard Deviation 4.48	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Inattention Symptom ADHD Score	-1.75 Units on a scale Standard Deviation 4.98	-1.30 Units on a scale Standard Deviation 5.22	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Items 19-26 of the CDBRS assess the presence of Oppositional Defiant Disorder (ODD) (yes if participant answers \>=4 items as 2 \[often\] or 3 \[very often\]). Items 1-26 are rated on a 0-3 scale (0=never/rarely, 1=sometimes, 2=often, 3=very often). 15 yes/no items assess the presence of Conduct Disorder (yes if \>3 items answered yes). Participants with a child 6-12 years old living in the home completed the scale.

Outcome measures

Outcome measures
Measure	Atomoxetine n=125 Participants 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 n=136 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags ODD Flag - Yes, Baseline	54 Participants	40 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags ODD Flag -No, Baseline	127 Participants	119 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags ODD Flag - Yes, 24 Weeks	40 Participants	33 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags ODD Flag -No, 24 Weeks	141 Participants	126 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags Conduct Disorder Flag - Yes, Baseline	13 Participants	14 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags Conduct Disorder Flag - No, Baseline	168 Participants	145 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags Conduct Disorder Flag - Yes, 24 Weeks	14 Participants	10 Participants	—
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags Conduct Disorder Flag - No, 24 Weeks	167 Participants	149 Participants	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=261 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale Total Score	3.51 Units on a scale Standard Deviation 7.95	2.52 Units on a scale Standard Deviation 6.44	—
Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale Satisfaction Scale	1.77 Units on a scale Standard Deviation 5.63	1.26 Units on a scale Standard Deviation 5.03	—
Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale Efficacy Scale	1.75 Units on a scale Standard Deviation 3.80	1.25 Units on a scale Standard Deviation 3.21	—

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=261 Participants 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 n=227 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale Total Score	4.57 Units on a scale Standard Deviation 8.57	2.93 Units on a scale Standard Deviation 7.19	—
Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale Satisfaction Scale	2.48 Units on a scale Standard Deviation 6.00	1.53 Units on a scale Standard Deviation 5.60	—
Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale Efficacy Scale	2.09 Units on a scale Standard Deviation 3.96	1.41 Units on a scale Standard Deviation 3.32	—

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

18-item scale that captures the 18-item 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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=235 Participants 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 n=202 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores Hyperactivity Score 12 Weeks (n=233, 202)	-5.84 Units on a scale Standard Deviation 6.18	-4.37 Units on a scale Standard Deviation 6.05	—
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores Inattention Score 24 Weeks (n=235, 202)	-7.62 Units on a scale Standard Deviation 6.96	-4.35 Units on a scale Standard Deviation 6.26	—
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores Total Score 12 Weeks (n=233, 201)	-13.26 Units on a scale Standard Deviation 11.95	-9.06 Units on a scale Standard Deviation 11.11	—
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores Inattention Score 12 Weeks (n=233, 201)	-7.42 Units on a scale Standard Deviation 6.77	-4.66 Units on a scale Standard Deviation 6.44	—
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores Total Score 24 Weeks (n=235, 202)	-13.66 Units on a scale Standard Deviation 12.54	-8.02 Units on a scale Standard Deviation 11.01	—
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores Hyperactivity Score 24 Weeks (n=235, 202)	-6.05 Units on a scale Standard Deviation 6.55	-3.68 Units on a scale Standard Deviation 5.79	—

SECONDARY outcome

Timeframe: Baseline, 8 weeks, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=264 Participants 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 n=232 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) 8 Weeks	-1.13 Units on a scale Standard Deviation 1.08	-0.69 Units on a scale Standard Deviation 0.91	—
Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) 24 Weeks	-1.18 Units on a scale Standard Deviation 1.18	-0.67 Units on a scale Standard Deviation 1.03	—

SECONDARY outcome

Timeframe: Baseline 12 weeks, 24 weeks

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).

Outcome measures

Outcome measures
Measure	Atomoxetine n=236 Participants 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 n=202 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS) 12 Weeks (n=235,202)	-0.69 Units on a scale Standard Deviation 5.90	0.14 Units on a scale Standard Deviation 6.25	—
Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS) 24 Weeks (n=236,202)	-0.61 Units on a scale Standard Deviation 6.53	0.36 Units on a scale Standard Deviation 6.19	—

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

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.

Outcome measures

Outcome measures
Measure	Atomoxetine n=233 Participants 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 n=198 Participants 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	Placebo Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) State Anxiety Score 24 Weeks (n=232, 198)	-0.40 Units on a scale Standard Deviation 13.22	0.38 Units on a scale Standard Deviation 12.44	—
Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) State Anxiety Score 12 Weeks (n=230, 197)	-1.50 Units on a scale Standard Deviation 11.96	1.12 Units on a scale Standard Deviation 11.91	—
Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) Trait Anxiety Score 12 Weeks (n=231, 198)	-5.67 Units on a scale Standard Deviation 9.65	-2.42 Units on a scale Standard Deviation 9.29	—
Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) Trait Anxiety Score 24 Weeks (n=233, 198)	-5.32 Units on a scale Standard Deviation 10.51	-2.77 Units on a scale Standard Deviation 9.60	—

SECONDARY outcome

Timeframe: Baseline, 1 week

Outcome measures

Outcome measures
Measure	Atomoxetine n=144 Participants 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 n=119 Participants 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	Placebo n=232 Participants Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores Total ADHD Symptoms Score (n=144, 119)	-7.92 Units on a scale Standard Deviation 8.51	-7.62 Units on a scale Standard Deviation 8.40	-5.12 Units on a scale Standard Deviation 8.34
Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores ADHD Index Subscale (n=143, 119)	-4.65 Units on a scale Standard Deviation 5.40	-4.30 Units on a scale Standard Deviation 5.59	-2.53 Units on a scale Standard Deviation 5.24
Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores Hyper/Impulsive Subscale (n=144, 119)	-3.21 Units on a scale Standard Deviation 4.41	-3.51 Units on a scale Standard Deviation 4.39	-2.41 Units on a scale Standard Deviation 4.56
Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores Inattention Subscale (n=144, 119)	-4.72 Units on a scale Standard Deviation 5.28	-4.11 Units on a scale Standard Deviation 5.28	-2.71 Units on a scale Standard Deviation 4.78

SECONDARY outcome

Timeframe: Baseline, 2 weeks

Outcome measures

Outcome measures
Measure	Atomoxetine n=144 Participants 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 n=119 Participants 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	Placebo n=232 Participants Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores Total ADHD Symptoms Score	-10.55 Units on a scale Standard Deviation 9.41	-10.58 Units on a scale Standard Deviation 10.24	-7.77 Units on a scale Standard Deviation 9.38
Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores Hyper/Impulsive Subscale	-4.61 Units on a scale Standard Deviation 4.53	-4.76 Units on a scale Standard Deviation 5.15	-3.43 Units on a scale Standard Deviation 5.02
Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores Inattention Subscale	-5.94 Units on a scale Standard Deviation 5.83	-5.83 Units on a scale Standard Deviation 6.39	-4.34 Units on a scale Standard Deviation 5.51
Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores ADHD Index Subscale	-6.09 Units on a scale Standard Deviation 6.11	-5.92 Units on a scale Standard Deviation 6.61	-4.00 Units on a scale Standard Deviation 5.70

SECONDARY outcome

Timeframe: Baseline, after 2-week titration period beginning at Week 24

Outcome measures

Outcome measures
Measure	Atomoxetine n=67 Participants 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 n=66 Participants 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	Placebo n=119 Participants Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo Total ADHD Symptoms Score	-4.54 Units on a scale Standard Deviation 7.23	-4.92 Units on a scale Standard Deviation 9.67	-0.17 Units on a scale Standard Deviation 5.89
Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo Hyper/Impulsive Subscale	-1.71 Units on a scale Standard Deviation 4.28	-2.00 Units on a scale Standard Deviation 4.71	-0.06 Units on a scale Standard Deviation 2.75
Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo Inattention Subscale	-2.82 Units on a scale Standard Deviation 4.32	-2.92 Units on a scale Standard Deviation 5.59	-0.12 Units on a scale Standard Deviation 3.79
Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo ADHD Index Subscale	-2.37 Units on a scale Standard Deviation 4.95	-2.91 Units on a scale Standard Deviation 6.72	-0.17 Units on a scale Standard Deviation 4.21

Adverse Events

Atomoxetine

Serious events: 4 serious events

Other events: 248 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 191 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atomoxetine n=266 participants at risk 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 n=234 participants at risk 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
Cardiac disorders Atrial fibrillation	0.38% 1/266 • Number of events 1 266 participants received study drug and were included in the safety analyses.	0.00% 0/234 266 participants received study drug and were included in the safety analyses.
Cardiac disorders Supraventricular tachycardia	0.38% 1/266 • Number of events 1 266 participants received study drug and were included in the safety analyses.	0.00% 0/234 266 participants received study drug and were included in the safety analyses.
Infections and infestations Appendicitis	0.38% 1/266 • Number of events 1 266 participants received study drug and were included in the safety analyses.	0.00% 0/234 266 participants received study drug and were included in the safety analyses.
Infections and infestations Localised infection	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.
Injury, poisoning and procedural complications Injury	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.38% 1/266 • Number of events 1 266 participants received study drug and were included in the safety analyses.	0.00% 0/234 266 participants received study drug and were included in the safety analyses.
Nervous system disorders Convulsion	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.
Nervous system disorders Syncope	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.
Psychiatric disorders Mental status changes	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.00% 0/266 266 participants received study drug and were included in the safety analyses.	0.43% 1/234 • Number of events 1 266 participants received study drug and were included in the safety analyses.

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Atomoxetine n=266 participants at risk 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 n=234 participants at risk 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
Gastrointestinal disorders Abdominal pain upper	5.3% 14/266 • Number of events 15 266 participants received study drug and were included in the safety analyses.	0.85% 2/234 • Number of events 2 266 participants received study drug and were included in the safety analyses.
Gastrointestinal disorders Constipation	6.4% 17/266 • Number of events 19 266 participants received study drug and were included in the safety analyses.	3.0% 7/234 • Number of events 7 266 participants received study drug and were included in the safety analyses.
Gastrointestinal disorders Dry mouth	25.9% 69/266 • Number of events 73 266 participants received study drug and were included in the safety analyses.	4.7% 11/234 • Number of events 11 266 participants received study drug and were included in the safety analyses.
Gastrointestinal disorders Nausea	34.2% 91/266 • Number of events 110 266 participants received study drug and were included in the safety analyses.	7.3% 17/234 • Number of events 20 266 participants received study drug and were included in the safety analyses.
Gastrointestinal disorders Vomiting	5.6% 15/266 • Number of events 15 266 participants received study drug and were included in the safety analyses.	2.6% 6/234 • Number of events 6 266 participants received study drug and were included in the safety analyses.
General disorders Fatigue	14.3% 38/266 • Number of events 43 266 participants received study drug and were included in the safety analyses.	8.5% 20/234 • Number of events 20 266 participants received study drug and were included in the safety analyses.
General disorders Irritability	9.4% 25/266 • Number of events 28 266 participants received study drug and were included in the safety analyses.	8.1% 19/234 • Number of events 21 266 participants received study drug and were included in the safety analyses.
Infections and infestations Nasopharyngitis	5.3% 14/266 • Number of events 15 266 participants received study drug and were included in the safety analyses.	12.4% 29/234 • Number of events 29 266 participants received study drug and were included in the safety analyses.
Infections and infestations Sinusitis	5.3% 14/266 • Number of events 15 266 participants received study drug and were included in the safety analyses.	3.8% 9/234 • Number of events 11 266 participants received study drug and were included in the safety analyses.
Infections and infestations Upper respiratory tract infection	4.9% 13/266 • Number of events 13 266 participants received study drug and were included in the safety analyses.	5.6% 13/234 • Number of events 15 266 participants received study drug and were included in the safety analyses.
Metabolism and nutrition disorders Decreased appetite	19.9% 53/266 • Number of events 55 266 participants received study drug and were included in the safety analyses.	4.3% 10/234 • Number of events 10 266 participants received study drug and were included in the safety analyses.
Musculoskeletal and connective tissue disorders Back pain	2.3% 6/266 • Number of events 6 266 participants received study drug and were included in the safety analyses.	6.0% 14/234 • Number of events 14 266 participants received study drug and were included in the safety analyses.
Nervous system disorders Dizziness	11.3% 30/266 • Number of events 34 266 participants received study drug and were included in the safety analyses.	4.7% 11/234 • Number of events 11 266 participants received study drug and were included in the safety analyses.
Nervous system disorders Headache	21.4% 57/266 • Number of events 68 266 participants received study drug and were included in the safety analyses.	26.5% 62/234 • Number of events 79 266 participants received study drug and were included in the safety analyses.
Nervous system disorders Paraesthesia	7.1% 19/266 • Number of events 19 266 participants received study drug and were included in the safety analyses.	0.85% 2/234 • Number of events 2 266 participants received study drug and were included in the safety analyses.
Nervous system disorders Somnolence	8.6% 23/266 • Number of events 24 266 participants received study drug and were included in the safety analyses.	3.8% 9/234 • Number of events 9 266 participants received study drug and were included in the safety analyses.
Psychiatric disorders Insomnia	13.2% 35/266 • Number of events 38 266 participants received study drug and were included in the safety analyses.	5.6% 13/234 • Number of events 13 266 participants received study drug and were included in the safety analyses.
Skin and subcutaneous tissue disorders Hyperhidrosis	6.0% 16/266 • Number of events 19 266 participants received study drug and were included in the safety analyses.	0.00% 0/234 266 participants received study drug and were included in the safety analyses.