Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.
Detailed description
The initial study was 34 weeks long; however, the protocol was amended to extend the open-label period of the study from 8 weeks to 12 weeks (38 weeks total).
Interventions
DRUGAtomoxetine Hydrochloride
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 60/80/100 mg as determined by the investigator up to 24 weeks, orally
DRUGPlacebo
Placebo is administered 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.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID). * Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) of 4 or greater Visit 2 and 3. * Adult Men and Women age 18 years or older at time informed consent is obtained. * Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating) with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study. * Must have one or more children 6-17 years of age living the home as the primary residence.
Exclusion criteria
* Anyone meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic disorder. * Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder. * Taking psychotropic medications on a regular basis. * Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial. * Previously taken an adequate trial of atomoxetine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 24 weeks | 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. |
| 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 | Baseline, 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | 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. |
| Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Baseline, 24 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. |
| Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | 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. |
| Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | 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. |
| Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | 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. |
| Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Baseline, 24 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. |
| Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress | 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. |
| Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | 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. |
| Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | 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. |
| Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress | Baseline, 24 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. |
| Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Baseline, 24 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. |
| Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Baseline, 24 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. |
| Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | 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. |
| Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Baseline, 8 weeks | 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. |
| Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | 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 child 6-12 or 13-17 years living at home. |
| Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Baseline, 24 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 child 6-12 or 13-17 years living at home. |
| Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form | 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. |
| 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 | 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. |
| Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale | 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. |
| Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale | Baseline, 24 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. |
| Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores | 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. |
| Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) | 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. |
| Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS) | 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). |
| Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) | 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. |
| Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores | Baseline, 1 week | 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. |
| Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores | Baseline, 2 weeks | 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. |
| 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 | Baseline, after 2-week titration period beginning at Week 24 | 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. |
| Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Baseline, 24 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. |
| Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Baseline, 24 weeks | 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. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 268 |
| 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 | 234 |
| Total | 502 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 57 | 22 |
| Overall Study | Exclusion Criteria Met | 1 | 3 |
| Overall Study | Lack of Efficacy | 28 | 32 |
| Overall Study | Lost to Follow-up | 31 | 23 |
| Overall Study | Noncompliance | 3 | 5 |
| Overall Study | Participant Moved | 0 | 1 |
| Overall Study | Physician Decision | 3 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Satisfactory Response | 1 | 0 |
| Overall Study | Sponsor Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 24 | 13 |
Baseline characteristics
| Characteristic | Total | Atomoxetine | Placebo |
|---|---|---|---|
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) AISRS Hyperactivity Score | 15.54 Units on a scale STANDARD_DEVIATION 5.85 | 15.16 Units on a scale STANDARD_DEVIATION 5.75 | 15.97 Units on a scale STANDARD_DEVIATION 5.94 |
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) AISRS Inattention Score | 20.77 Units on a scale STANDARD_DEVIATION 3.92 | 20.91 Units on a scale STANDARD_DEVIATION 3.83 | 20.62 Units on a scale STANDARD_DEVIATION 4.02 |
| Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) AISRS Total Score | 36.31 Units on a scale STANDARD_DEVIATION 7.97 | 36.07 Units on a scale STANDARD_DEVIATION 7.64 | 36.59 Units on a scale STANDARD_DEVIATION 8.34 |
| Age Continuous | 41.30 Years STANDARD_DEVIATION 7.17 | 41.21 Years STANDARD_DEVIATION 6.89 | 41.39 Years STANDARD_DEVIATION 7.49 |
| Alabama Parenting Questionnaire (APQ) Child Corporal Punishment | 4.92 Units on a scale STANDARD_DEVIATION 2.22 | 4.86 Units on a scale STANDARD_DEVIATION 2.08 | 4.99 Units on a scale STANDARD_DEVIATION 2.37 |
| Alabama Parenting Questionnaire (APQ) Child Inconsistent Discipline | 12.83 Units on a scale STANDARD_DEVIATION 3.5 | 12.66 Units on a scale STANDARD_DEVIATION 3.44 | 13.01 Units on a scale STANDARD_DEVIATION 3.57 |
| Alabama Parenting Questionnaire (APQ) Child Involvement Father | 31.90 Units on a scale STANDARD_DEVIATION 6.86 | 31.50 Units on a scale STANDARD_DEVIATION 6.85 | 32.35 Units on a scale STANDARD_DEVIATION 6.86 |
| Alabama Parenting Questionnaire (APQ) Child Involvement Mother | 35.67 Units on a scale STANDARD_DEVIATION 5.97 | 35.30 Units on a scale STANDARD_DEVIATION 6.02 | 36.09 Units on a scale STANDARD_DEVIATION 5.9 |
| Alabama Parenting Questionnaire (APQ) Child Other Discipline Practice | 17.88 Units on a scale STANDARD_DEVIATION 3.7 | 17.62 Units on a scale STANDARD_DEVIATION 3.52 | 18.18 Units on a scale STANDARD_DEVIATION 3.88 |
| Alabama Parenting Questionnaire (APQ) Child Poor Monitoring/Supervision | 17.09 Units on a scale STANDARD_DEVIATION 5.12 | 16.93 Units on a scale STANDARD_DEVIATION 4.92 | 17.27 Units on a scale STANDARD_DEVIATION 5.34 |
| Alabama Parenting Questionnaire (APQ) Child Positive Parenting | 23.64 Units on a scale STANDARD_DEVIATION 4.03 | 23.85 Units on a scale STANDARD_DEVIATION 4.04 | 23.40 Units on a scale STANDARD_DEVIATION 4.02 |
| Alabama Parenting Questionnaire (APQ) Parent Corporal Punishment | 4.74 Units on a scale STANDARD_DEVIATION 1.67 | 4.73 Units on a scale STANDARD_DEVIATION 1.6 | 4.75 Units on a scale STANDARD_DEVIATION 1.76 |
| Alabama Parenting Questionnaire (APQ) Parent Dysfunctional Parenting Composite | 0.14 Units on a scale STANDARD_DEVIATION 0.99 | 0.12 Units on a scale STANDARD_DEVIATION 0.98 | 0.17 Units on a scale STANDARD_DEVIATION 1.01 |
| Alabama Parenting Questionnaire (APQ) Parent Inconsistent Discipline | 15.42 Units on a scale STANDARD_DEVIATION 3.42 | 15.37 Units on a scale STANDARD_DEVIATION 3.44 | 15.48 Units on a scale STANDARD_DEVIATION 3.42 |
| Alabama Parenting Questionnaire (APQ) Parent Involvement | 37.67 Units on a scale STANDARD_DEVIATION 5.34 | 37.71 Units on a scale STANDARD_DEVIATION 5.11 | 37.61 Units on a scale STANDARD_DEVIATION 5.62 |
| Alabama Parenting Questionnaire (APQ) Parent Negative Parenting | 0.21 Units on a scale STANDARD_DEVIATION 1.02 | 0.21 Units on a scale STANDARD_DEVIATION 1.05 | 0.21 Units on a scale STANDARD_DEVIATION 0.99 |
| Alabama Parenting Questionnaire (APQ) Parent Other Discipline Practice | 19.58 Units on a scale STANDARD_DEVIATION 3.02 | 19.53 Units on a scale STANDARD_DEVIATION 3.08 | 19.64 Units on a scale STANDARD_DEVIATION 2.96 |
| Alabama Parenting Questionnaire (APQ) Parent Poor Monitoring Supervision | 16.58 Units on a scale STANDARD_DEVIATION 4.85 | 16.64 Units on a scale STANDARD_DEVIATION 4.91 | 16.50 Units on a scale STANDARD_DEVIATION 4.78 |
| Alabama Parenting Questionnaire (APQ) Parent Positive Parenting | 24.31 Units on a scale STANDARD_DEVIATION 3.42 | -0.00 Units on a scale STANDARD_DEVIATION 0.95 | 24.06 Units on a scale STANDARD_DEVIATION 3.58 |
| Attention Deficit Hyperactivity Disorder (ADHD) Subtype Combined | 345 Participants | 179 Participants | 166 Participants |
| Attention Deficit Hyperactivity Disorder (ADHD) Subtype Hyperactive/Impulsive | 1 Participants | 0 Participants | 1 Participants |
| Attention Deficit Hyperactivity Disorder (ADHD) Subtype Inattentive | 156 Participants | 89 Participants | 67 Participants |
| Body Mass Index (BMI) | 29.76 Kilograms/square meters STANDARD_DEVIATION 6.56 | 30.15 Kilograms/square meters STANDARD_DEVIATION 6.58 | 29.31 Kilograms/square meters STANDARD_DEVIATION 6.51 |
| Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Hyperactive-Impulsive Symptom ADHD Score | 11.09 Units on a scale STANDARD_DEVIATION 6.96 | 11.17 Units on a scale STANDARD_DEVIATION 6.98 | 11.00 Units on a scale STANDARD_DEVIATION 6.95 |
| Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Inattention Symptom ADHD Score | 13.37 Units on a scale STANDARD_DEVIATION 7.09 | 13.39 Units on a scale STANDARD_DEVIATION 7.3 | 13.35 Units on a scale STANDARD_DEVIATION 6.86 |
| Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Total Score | 24.46 Units on a scale STANDARD_DEVIATION 13.16 | 24.56 Units on a scale STANDARD_DEVIATION 13.3 | 24.35 Units on a scale STANDARD_DEVIATION 13.01 |
| Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) | 4.57 Units on a scale STANDARD_DEVIATION 0.61 | 4.56 Units on a scale STANDARD_DEVIATION 0.62 | 4.58 Units on a scale STANDARD_DEVIATION 0.6 |
| Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Hyper/Impulsive Subscale | 15.11 Units on a scale STANDARD_DEVIATION 5.86 | 14.67 Units on a scale STANDARD_DEVIATION 5.89 | 15.60 Units on a scale STANDARD_DEVIATION 5.8 |
| Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Inattention Subscale | 19.94 Units on a scale STANDARD_DEVIATION 4.39 | 19.97 Units on a scale STANDARD_DEVIATION 4.45 | 19.90 Units on a scale STANDARD_DEVIATION 4.33 |
| Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Index Subscale | 21.55 Units on a scale STANDARD_DEVIATION 5.54 | 21.60 Units on a scale STANDARD_DEVIATION 5.37 | 21.49 Units on a scale STANDARD_DEVIATION 5.74 |
| Conners' Adult ADHD Rating Scale Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score | 35.04 Units on a scale STANDARD_DEVIATION 8.46 | 34.64 Units on a scale STANDARD_DEVIATION 8.39 | 35.50 Units on a scale STANDARD_DEVIATION 8.53 |
| Dyadic Adjustment Scale (DAS) - Participant (Self) Affectional Expression | 44.24 T-scores of units on a scale STANDARD_DEVIATION 12.14 | 43.70 T-scores of units on a scale STANDARD_DEVIATION 12.52 | 44.85 T-scores of units on a scale STANDARD_DEVIATION 11.68 |
| Dyadic Adjustment Scale (DAS) - Participant (Self) Dyadic Cohesion | 52.08 T-scores of units on a scale STANDARD_DEVIATION 10.35 | 52.51 T-scores of units on a scale STANDARD_DEVIATION 10.63 | 51.58 T-scores of units on a scale STANDARD_DEVIATION 10.02 |
| Dyadic Adjustment Scale (DAS) - Participant (Self) Dyadic Consensus | 44.65 T-scores of units on a scale STANDARD_DEVIATION 8.98 | 44.99 T-scores of units on a scale STANDARD_DEVIATION 9.22 | 44.26 T-scores of units on a scale STANDARD_DEVIATION 8.69 |
| Dyadic Adjustment Scale (DAS) - Participant (Self) Dyadic Satisfaction | 42.75 T-scores of units on a scale STANDARD_DEVIATION 10.55 | 42.98 T-scores of units on a scale STANDARD_DEVIATION 10.82 | 42.49 T-scores of units on a scale STANDARD_DEVIATION 10.24 |
| Dyadic Adjustment Scale (DAS) - Participant (Self) Total Dyadic Adjustment | 42.74 T-scores of units on a scale STANDARD_DEVIATION 11.53 | 43.06 T-scores of units on a scale STANDARD_DEVIATION 11.9 | 42.37 T-scores of units on a scale STANDARD_DEVIATION 11.11 |
| Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Affectational Expression | 43.41 T-scores of units on a scale STANDARD_DEVIATION 12.1 | 43.18 T-scores of units on a scale STANDARD_DEVIATION 11.97 | 43.66 T-scores of units on a scale STANDARD_DEVIATION 12.28 |
| Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Cohesion | 51.51 T-scores of units on a scale STANDARD_DEVIATION 10.72 | 51.35 T-scores of units on a scale STANDARD_DEVIATION 11.09 | 51.70 T-scores of units on a scale STANDARD_DEVIATION 10.3 |
| Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Consensus | 40.64 T-scores of units on a scale STANDARD_DEVIATION 10.1 | 40.82 T-scores of units on a scale STANDARD_DEVIATION 10.18 | 40.44 T-scores of units on a scale STANDARD_DEVIATION 10.02 |
| Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Dyadic Satisfaction | 42.06 T-scores of units on a scale STANDARD_DEVIATION 10.64 | 42.25 T-scores of units on a scale STANDARD_DEVIATION 10.75 | 41.84 T-scores of units on a scale STANDARD_DEVIATION 10.53 |
| Dyadic Adjustment Scale (DAS) - Spouse/Significant Other Total Dyadic Adjustment | 41.85 T-scores of units on a scale STANDARD_DEVIATION 11.36 | 41.93 T-scores of units on a scale STANDARD_DEVIATION 11.44 | 41.75 T-scores of units on a scale STANDARD_DEVIATION 11.29 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Affective Expression | 61.59 T-scores of units on a scale STANDARD_DEVIATION 9.02 | 61.48 T-scores of units on a scale STANDARD_DEVIATION 8.63 | 61.71 T-scores of units on a scale STANDARD_DEVIATION 9.47 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Communication | 64.63 T-scores of units on a scale STANDARD_DEVIATION 6.43 | 64.97 T-scores of units on a scale STANDARD_DEVIATION 6.49 | 64.24 T-scores of units on a scale STANDARD_DEVIATION 6.35 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Control | 62.43 T-scores of units on a scale STANDARD_DEVIATION 6.01 | 62.70 T-scores of units on a scale STANDARD_DEVIATION 5.95 | 62.13 T-scores of units on a scale STANDARD_DEVIATION 6.07 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Involvement | 64.31 T-scores of units on a scale STANDARD_DEVIATION 7.66 | 64.07 T-scores of units on a scale STANDARD_DEVIATION 7.92 | 64.59 T-scores of units on a scale STANDARD_DEVIATION 7.35 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Role Performance | 60.96 T-scores of units on a scale STANDARD_DEVIATION 5.37 | 60.81 T-scores of units on a scale STANDARD_DEVIATION 5.03 | 61.13 T-scores of units on a scale STANDARD_DEVIATION 5.75 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Task Accomplishment | 62.59 T-scores of units on a scale STANDARD_DEVIATION 5.5 | 62.78 T-scores of units on a scale STANDARD_DEVIATION 5.56 | 62.38 T-scores of units on a scale STANDARD_DEVIATION 5.43 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Participant (Self) Values and Norms | 65.30 T-scores of units on a scale STANDARD_DEVIATION 7.06 | 65.66 T-scores of units on a scale STANDARD_DEVIATION 6.7 | 64.90 T-scores of units on a scale STANDARD_DEVIATION 7.44 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Affective Expression | 61.84 T-scores of units on a scale STANDARD_DEVIATION 9.39 | 61.97 T-scores of units on a scale STANDARD_DEVIATION 9.67 | 61.68 T-scores of units on a scale STANDARD_DEVIATION 9.07 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Communication | 63.78 T-scores of units on a scale STANDARD_DEVIATION 6.68 | 64.05 T-scores of units on a scale STANDARD_DEVIATION 6.37 | 63.47 T-scores of units on a scale STANDARD_DEVIATION 7.02 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Control | 61.68 T-scores of units on a scale STANDARD_DEVIATION 6.4 | 61.98 T-scores of units on a scale STANDARD_DEVIATION 6.52 | 61.34 T-scores of units on a scale STANDARD_DEVIATION 6.25 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Involvement | 64.76 T-scores of units on a scale STANDARD_DEVIATION 8.86 | 64.96 T-scores of units on a scale STANDARD_DEVIATION 8.95 | 64.52 T-scores of units on a scale STANDARD_DEVIATION 8.77 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Role Performance | 60.96 T-scores of units on a scale STANDARD_DEVIATION 5.83 | 61.28 T-scores of units on a scale STANDARD_DEVIATION 5.67 | 60.59 T-scores of units on a scale STANDARD_DEVIATION 6 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Task Accomplishment | 61.23 T-scores of units on a scale STANDARD_DEVIATION 5.91 | 61.52 T-scores of units on a scale STANDARD_DEVIATION 5.97 | 60.90 T-scores of units on a scale STANDARD_DEVIATION 5.83 |
| Family Assessment Measure III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other Values and Norms | 65.41 T-scores of units on a scale STANDARD_DEVIATION 7.13 | 65.32 T-scores of units on a scale STANDARD_DEVIATION 7.11 | 65.52 T-scores of units on a scale STANDARD_DEVIATION 7.17 |
| Height | 170.66 Centimeters STANDARD_DEVIATION 10.09 | 171.23 Centimeters STANDARD_DEVIATION 10.37 | 170.01 Centimeters STANDARD_DEVIATION 9.74 |
| Montgomery-Asberg Depression Rating Scale Total Score (MADRS) | 8.13 Units on a scale STANDARD_DEVIATION 4.89 | 8.13 Units on a scale STANDARD_DEVIATION 4.8 | 8.12 Units on a scale STANDARD_DEVIATION 5.01 |
| Parenting Sense of Competence (PSOC) Scale Efficacy Scale | 25.50 Units on a scale STANDARD_DEVIATION 4.54 | 25.18 Units on a scale STANDARD_DEVIATION 4.72 | 25.86 Units on a scale STANDARD_DEVIATION 4.31 |
| Parenting Sense of Competence (PSOC) Scale Satisfaction Scale | 34.15 Units on a scale STANDARD_DEVIATION 6.52 | 33.46 Units on a scale STANDARD_DEVIATION 6.58 | 34.94 Units on a scale STANDARD_DEVIATION 6.38 |
| Parenting Sense of Competence (PSOC) Scale Total | 59.65 Units on a scale STANDARD_DEVIATION 9.58 | 58.64 Units on a scale STANDARD_DEVIATION 9.83 | 60.80 Units on a scale STANDARD_DEVIATION 9.18 |
| Parent Stress Index (PSI) Child Domains Child Domain Acceptability | 15.59 Units on a scale STANDARD_DEVIATION 4.72 | 15.94 Units on a scale STANDARD_DEVIATION 4.75 | 15.18 Units on a scale STANDARD_DEVIATION 4.67 |
| Parent Stress Index (PSI) Child Domains Child Domain Adaptability | 47.96 Units on a scale STANDARD_DEVIATION 11.89 | 48.29 Units on a scale STANDARD_DEVIATION 11.56 | 47.59 Units on a scale STANDARD_DEVIATION 12.28 |
| Parent Stress Index (PSI) Child Domains Child Domain Demandingness | 20.85 Units on a scale STANDARD_DEVIATION 6.27 | 20.99 Units on a scale STANDARD_DEVIATION 6.09 | 20.71 Units on a scale STANDARD_DEVIATION 6.48 |
| Parent Stress Index (PSI) Child Domains Child Domain Distractibility/Hyperactivity | 27.54 Units on a scale STANDARD_DEVIATION 6.47 | 27.49 Units on a scale STANDARD_DEVIATION 6.46 | 27.59 Units on a scale STANDARD_DEVIATION 6.48 |
| Parent Stress Index (PSI) Child Domains Child Domain Mood | 12.25 Units on a scale STANDARD_DEVIATION 3.96 | 12.42 Units on a scale STANDARD_DEVIATION 3.89 | 12.06 Units on a scale STANDARD_DEVIATION 4.03 |
| Parent Stress Index (PSI) Child Domains Child Domain Reinforces Parent | 24.34 Units on a scale STANDARD_DEVIATION 7.12 | 24.87 Units on a scale STANDARD_DEVIATION 7.13 | 23.75 Units on a scale STANDARD_DEVIATION 7.07 |
| Parent Stress Index (PSI) Child Domains Child Domain Total | 148.54 Units on a scale STANDARD_DEVIATION 34.45 | 150.00 Units on a scale STANDARD_DEVIATION 34.46 | 146.88 Units on a scale STANDARD_DEVIATION 34.44 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Attachment | 13.37 Units on a scale STANDARD_DEVIATION 3.96 | 13.74 Units on a scale STANDARD_DEVIATION 4.21 | 12.95 Units on a scale STANDARD_DEVIATION 3.61 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Competence | 32.23 Units on a scale STANDARD_DEVIATION 6.89 | 32.63 Units on a scale STANDARD_DEVIATION 6.69 | 31.78 Units on a scale STANDARD_DEVIATION 7.1 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Depression | 21.96 Units on a scale STANDARD_DEVIATION 5.97 | 22.79 Units on a scale STANDARD_DEVIATION 6.1 | 21.01 Units on a scale STANDARD_DEVIATION 5.68 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Health | 13.63 Units on a scale STANDARD_DEVIATION 2.67 | 13.72 Units on a scale STANDARD_DEVIATION 2.71 | 13.52 Units on a scale STANDARD_DEVIATION 2.62 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Isolation | 15.06 Units on a scale STANDARD_DEVIATION 4.68 | 15.49 Units on a scale STANDARD_DEVIATION 4.71 | 14.56 Units on a scale STANDARD_DEVIATION 4.61 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Role Restriction | 18.62 Units on a scale STANDARD_DEVIATION 5.18 | 18.93 Units on a scale STANDARD_DEVIATION 5.33 | 18.26 Units on a scale STANDARD_DEVIATION 4.99 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Spouse | 18.17 Units on a scale STANDARD_DEVIATION 5.03 | 18.19 Units on a scale STANDARD_DEVIATION 5.03 | 18.14 Units on a scale STANDARD_DEVIATION 5.04 |
| Parent Stress Index (PSI) Parent Domains Parent Domain Total | 132.98 Units on a scale STANDARD_DEVIATION 25.05 | 135.40 Units on a scale STANDARD_DEVIATION 25.22 | 130.22 Units on a scale STANDARD_DEVIATION 24.62 |
| Parent Stress Index (PSI) Total Stress and Life Stress Life Stress | 1.66 Units on a scale STANDARD_DEVIATION 3.62 | 1.57 Units on a scale STANDARD_DEVIATION 3.56 | 1.76 Units on a scale STANDARD_DEVIATION 3.68 |
| Parent Stress Index (PSI) Total Stress and Life Stress Total Stress | 281.53 Units on a scale STANDARD_DEVIATION 53.18 | 285.40 Units on a scale STANDARD_DEVIATION 53.45 | 277.11 Units on a scale STANDARD_DEVIATION 52.65 |
| Previous Stimulant Exposure No | 418 Participants | 220 Participants | 198 Participants |
| Previous Stimulant Exposure Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Previous Stimulant Exposure Yes | 82 Participants | 47 Participants | 35 Participants |
| Race/Ethnicity, Customized African Descent | 17 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 426 Participants | 227 Participants | 199 Participants |
| Race/Ethnicity, Customized East/Southeast Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 44 Participants | 24 Participants | 20 Participants |
| Race/Ethnicity, Customized Other | 12 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Western Asian | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Puerto Rico | 23 Participants | 13 Participants | 10 Participants |
| Region of Enrollment United States | 479 Participants | 255 Participants | 224 Participants |
| Sex: Female, Male Female | 263 Participants | 131 Participants | 132 Participants |
| Sex: Female, Male Male | 239 Participants | 137 Participants | 102 Participants |
| State-Trait Anxiety Inventories (STAI) State Anxiety Score | 40.61 Units on a scale STANDARD_DEVIATION 11.38 | 40.13 Units on a scale STANDARD_DEVIATION 11.55 | 41.16 Units on a scale STANDARD_DEVIATION 11.18 |
| State-Trait Anxiety Inventories (STAI) Trait Anxiety Score | 46.79 Units on a scale STANDARD_DEVIATION 10.94 | 47.44 Units on a scale STANDARD_DEVIATION 10.68 | 46.05 Units on a scale STANDARD_DEVIATION 11.22 |
| Weight | 86.65 Kilograms STANDARD_DEVIATION 20.14 | 88.22 Kilograms STANDARD_DEVIATION 20.4 | 84.84 Kilograms STANDARD_DEVIATION 19.72 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 248 / 266 | 191 / 234 |
| serious Total, serious adverse events | 4 / 266 | 3 / 234 |
Outcome results
Primary
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
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time frame: Baseline, 12 weeks
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | 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 |
| Placebo | 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 | -10.05 Units on a scale | Standard Error 0.82 |
Comparison: Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.p-value: 0.001Mixed Models Analysis
Primary
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
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time frame: Baseline, 24 weeks
Population: Participants with a baseline and at least one post-baseline CAARS Total ADHD Symptoms Score were included.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine | 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 |
| Placebo | 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 | -8.65 Units on a scale | Standard Error 0.85 |
Comparison: Approximately 500 participants were randomized to atomoxetine or placebo (1:1) which provided at least 90% power to detect a treatment difference of 3.64 points on the CAARS-Inv:SV Total ADHD Symptoms Score assuming a SD of 9.85 based on 2-sided significance level of 0.05 using a 2-sample t-test. Mean and SD assumptions were associated with effect size of 0.37 and 30% missing data rate. These assumptions applied to Weeks 12 and 24 treatment effects. Marginal power at Weeks 12 and 24 was 86%.p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores
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.
Time frame: Baseline, 12 weeks, 24 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | 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) | -3.68 Units on a scale | Standard Deviation 5.79 |
| Placebo | 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) | -9.06 Units on a scale | Standard Deviation 11.11 |
| Placebo | 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) | -8.02 Units on a scale | Standard Deviation 11.01 |
| Placebo | 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) | -4.37 Units on a scale | Standard Deviation 6.05 |
| Placebo | 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) | -4.35 Units on a scale | Standard Deviation 6.26 |
| Placebo | 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) | -4.66 Units on a scale | Standard Deviation 6.44 |
p-value: 0.001ANCOVA
p-value: 0.004ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS)
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).
Time frame: Baseline 12 weeks, 24 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 5.9 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS) | 12 Weeks (n=235,202) | 0.14 Units on a scale | Standard Deviation 6.25 |
| Placebo | Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS) | 24 Weeks (n=236,202) | 0.36 Units on a scale | Standard Deviation 6.19 |
p-value: 0.553ANCOVA
p-value: 0.797ANCOVA
Secondary
Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI)
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.
Time frame: Baseline, 12 weeks, 24 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) | Trait Anxiety Score 24 Weeks (n=233, 198) | -2.77 Units on a scale | Standard Deviation 9.6 |
| Placebo | Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) | State Anxiety Score 12 Weeks (n=230, 197) | 1.12 Units on a scale | Standard Deviation 11.91 |
| Placebo | Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) | State Anxiety Score 24 Weeks (n=232, 198) | 0.38 Units on a scale | Standard Deviation 12.44 |
| Placebo | Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) | Trait Anxiety Score 12 Weeks (n=231, 198) | -2.42 Units on a scale | Standard Deviation 9.29 |
p-value: 0.108ANCOVA
p-value: 0.026ANCOVA
p-value: 0.897ANCOVA
p-value: 0.171ANCOVA
Secondary
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
42-item scale, 3 subscales (z-scores \[-2 to 2\]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.
Time frame: Baseline, 12 Weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 5.4 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Other Discipline Practice (n=189, 159) | -0.27 Units on a scale | Standard Deviation 3.77 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Involvement Mother (n=189, 158) | -0.17 Units on a scale | Standard Deviation 5.41 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Involvement Father (n=188, 159) | -0.15 Units on a scale | Standard Deviation 5.37 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Positive Parenting (n=188, 159) | -0.24 Units on a scale | Standard Deviation 3.98 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Poor Supervision (n=188, 158) | -1.23 Units on a scale | Standard Deviation 4.27 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Inconsistent Discipline (n=189,159) | -0.81 Units on a scale | Standard Deviation 3.67 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Corporal Punishment (n=189, 160) | -0.31 Units on a scale | Standard Deviation 1.66 |
p-value: 0.895ANCOVA
p-value: 0.792ANCOVA
p-value: 0.318ANCOVA
p-value: 0.914ANCOVA
p-value: 0.961ANCOVA
p-value: 0.807ANCOVA
p-value: 0.827ANCOVA
Secondary
Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
42-item scale, 3 subscales (z-scores \[-2 to 2\]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.
Time frame: Baseline, 12 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Positive Parenting Composite (n=230, 192) | 0.13 Units on a scale | Standard Deviation 0.64 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Involvement (n=230, 192) | 0.67 Units on a scale | Standard Deviation 3.57 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Positive Parenting (n=230, 192) | 0.36 Units on a scale | Standard Deviation 2.33 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Poor Supervision (n=229, 191) | -1.17 Units on a scale | Standard Deviation 3.43 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Inconsistent Discipline (n=230, 192) | -0.81 Units on a scale | Standard Deviation 2.59 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Corporal Punishment (n=230, 192) | -0.21 Units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Other Discipline Practice (n=230, 190) | 0.00 Units on a scale | Standard Deviation 2.57 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Dysfunctional Parenting Composite (n=229, 191) | -0.26 Units on a scale | Standard Deviation 0.65 |
| Placebo | Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Negative Parenting Composite (n=229, 191) | -0.32 Units on a scale | Standard Deviation 0.74 |
p-value: 0.42ANCOVA
p-value: 0.249ANCOVA
p-value: 0.927ANCOVA
p-value: 0.205ANCOVA
p-value: 0.673ANCOVA
p-value: 0.881ANCOVA
p-value: 0.808ANCOVA
p-value: 0.498ANCOVA
p-value: 0.283ANCOVA
Secondary
Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time frame: Baseline, 1 week
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 5.4 |
| Placebo | 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) | -4.30 Units on a scale | Standard Deviation 5.59 |
| Placebo | 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) | -7.62 Units on a scale | Standard Deviation 8.4 |
| Placebo | 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) | -4.11 Units on a scale | Standard Deviation 5.28 |
| Placebo | 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) | -3.51 Units on a scale | Standard Deviation 4.39 |
| Placebo | 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) | -2.53 Units on a scale | Standard Deviation 5.24 |
| Placebo | 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) | -2.41 Units on a scale | Standard Deviation 4.56 |
| Placebo | 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) | -2.71 Units on a scale | Standard Deviation 4.78 |
| Placebo | 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) | -5.12 Units on a scale | Standard Deviation 8.34 |
p-value: 0.892ANCOVA
p-value: 0.003ANCOVA
p-value: 0.007ANCOVA
p-value: 0.533ANCOVA
p-value: 0.054ANCOVA
p-value: 0.012ANCOVA
p-value: 0.457ANCOVA
p-value: 0.001ANCOVA
p-value: 0.021ANCOVA
p-value: 0.71ANCOVA
p-value: <0.001ANCOVA
p-value: 0.005ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form
42-item scale, 3 subscales (z-scores \[-2 to 2\]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by child 6-12 or 13-17 years living at home.
Time frame: Baseline, 24 Weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 4.6 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Other Discipline Practice (n=189, 159) | -0.19 Units on a scale | Standard Deviation 4.02 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Involvement Mother (n=189, 159) | -0.11 Units on a scale | Standard Deviation 5.41 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Involvement Father (n=188, 159) | 0.44 Units on a scale | Standard Deviation 5.48 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Positive Parenting (n=188, 159) | -0.33 Units on a scale | Standard Deviation 4.05 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Poor Supervision (n=188, 158) | -1.31 Units on a scale | Standard Deviation 4.13 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Inconsistent Discipline (n=189, 159) | -0.86 Units on a scale | Standard Deviation 3.73 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form | Child Corporal Punishment (n=189, 160) | -0.34 Units on a scale | Standard Deviation 1.95 |
p-value: 0.828ANCOVA
p-value: 0.401ANCOVA
p-value: 0.3ANCOVA
p-value: 0.575ANCOVA
p-value: 0.772ANCOVA
p-value: 0.918ANCOVA
p-value: 0.636ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form
42-item scale, 3 subscales (z-scores \[-2 to 2\]): Dysfunctional/Negative/Positive Parenting. Each construct rated 1=never/5=always (# items): involvement (10), supervision (10), positive parenting (6), inconsistent discipline (6), other discipline (7), harsh discipline (3). Higher scores indicate impairment: dysfunctional/negative parenting composite; supervision, inconsistent discipline, harsh punishment, other discipline. Lower scores indicate impairment: positive parenting composite; positive parenting, involvement. Completed by participants with a child 6-12 or 13-17 years living at home.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 0.8 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Positive Parenting Composite (n=230, 192) | 0.07 Units on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Involvement (n=230, 192) | 0.43 Units on a scale | Standard Deviation 3.47 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Positive Parenting (n=230, 192) | 0.11 Units on a scale | Standard Deviation 2.35 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Poor Supervision (n=229, 191) | -0.96 Units on a scale | Standard Deviation 3.31 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Inconsistent Discipline (n=230, 192) | -0.82 Units on a scale | Standard Deviation 2.75 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Parent Corporal Punishment (n=230, 192) | -0.14 Units on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Other Discipline Practice (n=230, 190) | 0.18 Units on a scale | Standard Deviation 2.27 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Dysfunctional Parenting Composite (n=229, 191) | -0.20 Units on a scale | Standard Deviation 0.56 |
| Placebo | Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form | Negative Parenting Composite (n=229, 191) | -0.28 Units on a scale | Standard Deviation 0.71 |
p-value: 0.784ANCOVA
p-value: 0.864ANCOVA
p-value: 0.884ANCOVA
p-value: 0.072ANCOVA
p-value: 0.12ANCOVA
p-value: 0.925ANCOVA
p-value: 0.444ANCOVA
p-value: 0.166ANCOVA
p-value: 0.875ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores \<30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Dyadic Cohesion | 0.16 T-scores of units on a scale | Standard Deviation 8.01 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Total Dyadic Adjustment | 0.51 T-scores of units on a scale | Standard Deviation 7.74 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Dyadic Consensus | 1.58 T-scores of units on a scale | Standard Deviation 8.34 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Dyadic Satisfaction | -0.32 T-scores of units on a scale | Standard Deviation 6.13 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Affectional Expression | -1.13 T-scores of units on a scale | Standard Deviation 9.93 |
p-value: 0.544ANCOVA
p-value: 0.494ANCOVA
p-value: 0.547ANCOVA
p-value: 0.059ANCOVA
p-value: 0.918ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other
32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores \<30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 7.7 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Dyadic Cohesion | 0.99 T-scores of units on a scale | Standard Deviation 7.6 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Total Dyadic Adjustment | 2.84 T-scores of units on a scale | Standard Deviation 6.8 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Dyadic Consensus | 3.87 T-scores of units on a scale | Standard Deviation 7.22 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Dyadic Satisfaction | 1.27 T-scores of units on a scale | Standard Deviation 6.47 |
| Placebo | Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Affectional Expression | 2.00 T-scores of units on a scale | Standard Deviation 8 |
p-value: 0.248ANCOVA
p-value: 0.163ANCOVA
p-value: 0.947ANCOVA
p-value: 0.214ANCOVA
p-value: 0.543ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores \>=60 indicate disturbance in family functioning.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 5.6 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Values and Norms | 0.31 T-scores of units on a scale | Standard Deviation 8.21 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Task Accomplishment | -0.90 T-scores of units on a scale | Standard Deviation 6.59 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Role Performance | 0.27 T-scores of units on a scale | Standard Deviation 6.65 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Communication | -0.58 T-scores of units on a scale | Standard Deviation 6.73 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Affective Expression | 0.25 T-scores of units on a scale | Standard Deviation 8.1 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Involvement | 0.56 T-scores of units on a scale | Standard Deviation 7.32 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Control | 0.41 T-scores of units on a scale | Standard Deviation 6.21 |
p-value: 0.176ANCOVA
p-value: 0.122ANCOVA
p-value: 0.931ANCOVA
p-value: 0.788ANCOVA
p-value: 0.19ANCOVA
p-value: 0.36ANCOVA
p-value: 0.446ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores \>=60 indicate disturbance in family functioning.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Values and Norms | -0.57 T-scores of units on a scale | Standard Deviation 7.34 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Task Accomplishment | 0.24 T-scores of units on a scale | Standard Deviation 6.99 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Role Performance | -0.41 T-scores of units on a scale | Standard Deviation 6.37 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Communication | -0.09 T-scores of units on a scale | Standard Deviation 7.17 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Affective Expression | 0.60 T-scores of units on a scale | Standard Deviation 8.79 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Involvement | -0.10 T-scores of units on a scale | Standard Deviation 7.69 |
| Placebo | Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Control | 0.73 T-scores of units on a scale | Standard Deviation 6.69 |
p-value: 0.941ANCOVA
p-value: 0.788ANCOVA
p-value: 0.391ANCOVA
p-value: 0.685ANCOVA
p-value: 0.774ANCOVA
p-value: 0.36ANCOVA
p-value: 0.446ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale
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.
Time frame: Baseline, 24 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale | Total Score | 2.93 Units on a scale | Standard Deviation 7.19 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale | Satisfaction Scale | 1.53 Units on a scale | Standard Deviation 5.6 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale | Efficacy Scale | 1.41 Units on a scale | Standard Deviation 3.32 |
p-value: 0.365ANCOVA
p-value: 0.62ANCOVA
p-value: 0.462ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains
120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics' subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score \>=116 (\>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Acceptability | -0.56 Units on a scale | Standard Deviation 3.51 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Total | -7.85 Units on a scale | Standard Deviation 20.07 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Reinforces Parent | -0.63 Units on a scale | Standard Deviation 4.96 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Defensive Responding | -0.84 Units on a scale | Standard Deviation 5.2 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Mood | -0.33 Units on a scale | Standard Deviation 3.02 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Distractibility/Hyperactive | -2.60 Units on a scale | Standard Deviation 4.35 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Demandingness | -1.30 Units on a scale | Standard Deviation 4.19 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Adaptability | -2.44 Units on a scale | Standard Deviation 7.28 |
p-value: 0.785ANCOVA
p-value: 0.081ANCOVA
p-value: 0.518ANCOVA
p-value: 0.883ANCOVA
p-value: 0.439ANCOVA
p-value: 0.167ANCOVA
p-value: 0.381ANCOVA
p-value: 0.906ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains
120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics' subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score \>=148 (\>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Spouse | -0.48 Units on a scale | Standard Deviation 3.7 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Total | -3.12 Units on a scale | Standard Deviation 15.18 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Health | 0.07 Units on a scale | Standard Deviation 2.45 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Competence | -1.57 Units on a scale | Standard Deviation 4.54 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Depression | -0.54 Units on a scale | Standard Deviation 4.29 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Isolation | -0.28 Units on a scale | Standard Deviation 3.17 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Role Restriction | -0.31 Units on a scale | Standard Deviation 4 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Attachment | -0.01 Units on a scale | Standard Deviation 2.57 |
p-value: 0.103ANCOVA
p-value: 0.182ANCOVA
p-value: 0.161ANCOVA
p-value: 0.472ANCOVA
p-value: 0.949ANCOVA
p-value: 0.848ANCOVA
p-value: 0.05ANCOVA
p-value: 0.84ANCOVA
Secondary
Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress
The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score \>=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (\>=85th percentile) indicate higher stress. Total Stress \>=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress | Total Stress | -10.97 Units on a scale | Standard Deviation 31.33 |
| Placebo | Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress | Life Stress | 0.19 Units on a scale | Standard Deviation 4.93 |
p-value: 0.28ANCOVA
p-value: 0.34ANCOVA
Secondary
Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time frame: Baseline, 2 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | 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 | -5.92 Units on a scale | Standard Deviation 6.61 |
| Placebo | 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 | -10.58 Units on a scale | Standard Deviation 10.24 |
| Placebo | 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 | -5.83 Units on a scale | Standard Deviation 6.39 |
| Placebo | 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 | -4.76 Units on a scale | Standard Deviation 5.15 |
| Placebo | 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 | -4.00 Units on a scale | Standard Deviation 5.7 |
| Placebo | 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 | -3.43 Units on a scale | Standard Deviation 5.02 |
| Placebo | 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 | -4.34 Units on a scale | Standard Deviation 5.51 |
| Placebo | 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 | -7.77 Units on a scale | Standard Deviation 9.38 |
p-value: 0.722ANCOVA
p-value: 0.011ANCOVA
p-value: 0.005ANCOVA
p-value: 0.779ANCOVA
p-value: 0.004ANCOVA
p-value: 0.002ANCOVA
p-value: 0.716ANCOVA
p-value: 0.071ANCOVA
p-value: 0.034ANCOVA
p-value: 0.938ANCOVA
p-value: 0.004ANCOVA
p-value: 0.005ANCOVA
Secondary
Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S)
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.
Time frame: Baseline, 8 weeks, 24 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) | 8 Weeks | -0.69 Units on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) | 24 Weeks | -0.67 Units on a scale | Standard Deviation 1.03 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
32-item self-report scale to assess quality of the relationship perceived by participants. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), consensus (13), affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, standard deviation (SD)=10). T-scores of 45-55 indicate a typical score (no concern). Scores \<30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Dyadic Cohesion | 0.54 T-scores of units on a scale | Standard Deviation 6.86 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Total Dyadic Adjustment | 0.70 T-scores of units on a scale | Standard Deviation 6.55 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Dyadic Consensus | 1.42 T-scores of units on a scale | Standard Deviation 7.22 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Dyadic Satisfaction | -0.02 T-scores of units on a scale | Standard Deviation 5.53 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant | Affectional Expression | -0.85 T-scores of units on a scale | Standard Deviation 8.27 |
p-value: 0.617ANCOVA
p-value: 0.789ANCOVA
p-value: 0.67ANCOVA
p-value: 0.018ANCOVA
p-value: 0.405ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other
32-item self-report scale to assess quality of the relationship perceived by the spouse/significant other. Response anchors vary and include a 5-, 6- or 7-point Likert scale (always agree/disagree; all the time/never); and 2 yes/no items. Assesses 4 relationship aspects (# items): dyadic satisfaction (10), cohesion (5), and consensus (13), and affectional expression (4). Raw score total=0-151 and is converted to a t-score (0-100; mean=50, SD=10). T-scores of 45-55 indicate a typical score (no concern). Scores \<30 indicate significant impairment. Lower scores indicate poorer dyadic adjustment.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 9.4 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Dyadic Cohesion | 0.29 T-scores of units on a scale | Standard Deviation 8.23 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Total Dyadic Adjustment | 2.64 T-scores of units on a scale | Standard Deviation 7.13 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Dyadic Consensus | 3.67 T-scores of units on a scale | Standard Deviation 7.92 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Dyadic Satisfaction | 1.61 T-scores of units on a scale | Standard Deviation 6.36 |
| Placebo | Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other | Affectional Expression | 1.23 T-scores of units on a scale | Standard Deviation 9.57 |
p-value: 0.334ANCOVA
p-value: 0.087ANCOVA
p-value: 0.795ANCOVA
p-value: 0.955ANCOVA
p-value: 0.788ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. Participants completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores \>=60 indicate disturbance in family functioning.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 7.5 |
| Atomoxetine | 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 |
| Atomoxetine | 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 5.3 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Values and Norms | -0.27 T-scores of units on a scale | Standard Deviation 8.02 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Task Accomplishment | -0.41 T-scores of units on a scale | Standard Deviation 6.37 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Role Performance | -0.04 T-scores of units on a scale | Standard Deviation 6.18 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Communication | -0.29 T-scores of units on a scale | Standard Deviation 6.88 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Affective Expression | -0.33 T-scores of units on a scale | Standard Deviation 7.86 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Involvement | 0.17 T-scores of units on a scale | Standard Deviation 7.54 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant | Control | 0.33 T-scores of units on a scale | Standard Deviation 6.56 |
p-value: 0.905ANCOVA
p-value: 0.491ANCOVA
p-value: 0.6ANCOVA
p-value: 0.052ANCOVA
p-value: 0.514ANCOVA
p-value: 0.515ANCOVA
p-value: 0.315ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
FAM consists of 3 components: General Scale; Dyadic Relationships Scale (DRS), and Self-Rating Scale. The spouse/significant other completed the DRS scale, a 42-item self-report scale providing quantitative indices of family strengths/weaknesses. Items are rated 0-3 (strongly agree, agree, disagree, strongly disagree). Raw scores=0-18 (each subscale) and are converted to a t-score (mean=50, standard deviation (SD)=10; scores range from 0-100). T-scores should be between 40-60. T-scores \>=60 indicate disturbance in family functioning.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 7.5 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 8.3 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Values and Norms | -0.95 T-scores of units on a scale | Standard Deviation 7.08 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Task Accomplishment | 0.15 T-scores of units on a scale | Standard Deviation 7.1 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Role Performance | -0.35 T-scores of units on a scale | Standard Deviation 6.33 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Communication | -0.05 T-scores of units on a scale | Standard Deviation 7.21 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Affective Expression | 0.32 T-scores of units on a scale | Standard Deviation 8.83 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Involvement | 0.11 T-scores of units on a scale | Standard Deviation 7.81 |
| Placebo | Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other | Control | 0.54 T-scores of units on a scale | Standard Deviation 6.78 |
p-value: 0.575ANCOVA
p-value: 0.705ANCOVA
p-value: 0.686ANCOVA
p-value: 0.618ANCOVA
p-value: 0.903ANCOVA
p-value: 0.807ANCOVA
p-value: 0.403ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale | Efficacy Scale | 1.75 Units on a scale | Standard Deviation 3.8 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale | Total Score | 2.52 Units on a scale | Standard Deviation 6.44 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale | Satisfaction Scale | 1.26 Units on a scale | Standard Deviation 5.03 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale | Efficacy Scale | 1.25 Units on a scale | Standard Deviation 3.21 |
p-value: 0.875ANCOVA
p-value: 0.569ANCOVA
p-value: 0.399ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains
120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Child Domain characteristics' subscales and score ranges include: Distractibility/Hyperactivity (9-45), Adaptability (11-55), Reinforces Parent (6-30), Demandingness (9-45), Mood (5-25), Acceptability (7-35). Total Score measures relative magnitude of stress in parent-child system. A Child Domain score \>=116 (\>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Acceptability | -0.34 Units on a scale | Standard Deviation 3.31 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Total | -5.72 Units on a scale | Standard Deviation 18.62 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Reinforces Parent | -0.32 Units on a scale | Standard Deviation 4.44 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Defensive Responding | -0.35 Units on a scale | Standard Deviation 4.75 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Mood | -0.26 Units on a scale | Standard Deviation 2.67 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Distractibility/Hyperactive | -1.93 Units on a scale | Standard Deviation 4.11 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Demandingness | -1.00 Units on a scale | Standard Deviation 3.99 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains | Child Domain Adaptability | -1.87 Units on a scale | Standard Deviation 7.23 |
p-value: 0.578ANCOVA
p-value: 0.062ANCOVA
p-value: 0.567ANCOVA
p-value: 0.383ANCOVA
p-value: 0.963ANCOVA
p-value: 0.075ANCOVA
p-value: 0.854ANCOVA
p-value: 0.671ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains
120-item scale includes 101 items rated on 5-point Likert scale (strongly agree/strongly disagree) or 4-5 point multiple choices. Adult Domain characteristics' subscales and score ranges include: Competence (13-65), Isolation (6-30), Attachment (7-35), Health (5-25), Role Restriction (7-35), Depression (9-45), Spouse (7-35). Total Score measures relative magnitude of stress in parent-child system. Parent Domain score \>=148 (\>=85th percentile) is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 17.4 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 4.7 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Spouse | -0.32 Units on a scale | Standard Deviation 3.72 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Total | -1.34 Units on a scale | Standard Deviation 12.95 |
| Placebo | 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 2.18 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Competence | -1.24 Units on a scale | Standard Deviation 4.26 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Depression | -0.08 Units on a scale | Standard Deviation 3.78 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Isolation | -0.11 Units on a scale | Standard Deviation 2.97 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Role Restriction | 0.06 Units on a scale | Standard Deviation 3.75 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains | Parent Domain Attachment | 0.40 Units on a scale | Standard Deviation 2.74 |
p-value: 0.056ANCOVA
p-value: 0.459ANCOVA
p-value: 0.435ANCOVA
p-value: 0.677ANCOVA
p-value: 0.376ANCOVA
p-value: 0.176ANCOVA
p-value: 0.03ANCOVA
p-value: 0.434ANCOVA
Secondary
Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress
The PSI 19-item Stress Life Events scale has yes/no responses and measures situational circumstances beyond control (death of family member, divorce, etc.) in the past 12 months. Maximum score (all answers=yes) is 79; a Life Stress raw score \>=17 indicates high stress. Each question is weighted based upon the event. Total Score measures relative magnitude of stress in parent-child system. High scores (\>=85th percentile) indicate higher stress. Total Stress \>=258 is indicative of impairment. Participants with a child aged 6-12 or 13-17 years living at home completed the scale.
Time frame: Baseline, 8 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress | Total Stress | -7.06 Units on a scale | Standard Deviation 26.63 |
| Placebo | Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress | Life Stress | -0.30 Units on a scale | Standard Deviation 4.04 |
p-value: 0.446ANCOVA
p-value: 0.134ANCOVA
Secondary
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
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Time frame: Baseline, after 2-week titration period beginning at Week 24
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | 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 | -2.91 Units on a scale | Standard Deviation 6.72 |
| Placebo | 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 | -4.92 Units on a scale | Standard Deviation 9.67 |
| Placebo | 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 | -2.92 Units on a scale | Standard Deviation 5.59 |
| Placebo | 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 | -2.00 Units on a scale | Standard Deviation 4.71 |
| Placebo | 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 | -0.17 Units on a scale | Standard Deviation 4.21 |
| Placebo | 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 | -0.06 Units on a scale | Standard Deviation 2.75 |
| Placebo | 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 | -0.12 Units on a scale | Standard Deviation 3.79 |
| Placebo | 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 | -0.17 Units on a scale | Standard Deviation 5.89 |
p-value: 0.546ANCOVA
p-value: 0.53ANCOVA
p-value: 0.569ANCOVA
p-value: 0.986ANCOVA
Secondary
Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form
Contains the symptoms of ADHD (9 items for Inattention/9 items for Hyperactive-Impulsive). Total maximum severity score is 54 (0-27 for each subscale). Higher scores indicate greater impairment. Participants with a child 6-12 years old living in the home completed the scale.
Time frame: Baseline, 24 weeks
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form | Total ADHD Score | -2.57 Units on a scale | Standard Deviation 8.91 |
| Placebo | Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form | Hyperactive-Impulsive Symptom ADHD Score | -1.26 Units on a scale | Standard Deviation 4.48 |
| Placebo | Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form | Inattention Symptom ADHD Score | -1.30 Units on a scale | Standard Deviation 5.22 |
p-value: 0.583ANCOVA
p-value: 0.997ANCOVA
p-value: 0.333ANCOVA
Secondary
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
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.
Time frame: Baseline, 24 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Atomoxetine | 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 |
| Placebo | 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 | 149 Participants |
| Placebo | 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 | 40 Participants |
| Placebo | 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 | 14 Participants |
| Placebo | 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 | 119 Participants |
| Placebo | 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 | 10 Participants |
| Placebo | 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 | 33 Participants |
| Placebo | 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 | 145 Participants |
| Placebo | 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 | 126 Participants |
p-value: 0.792Fisher Exact
p-value: 0.675Fisher Exact