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Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00510276
Collaborator
(none)
445
Enrollment
29
Locations
2
Arms
18.1
Duration (Months)
15.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atomoxetine hydrochloride
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
445 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atomoxetine

Drug: Atomoxetine hydrochloride
20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
Other Names:
  • LY139603
  • Strattera

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    twice a day, by mouth for 12 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint [Baseline, Week 12]

      CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.

    Secondary Outcome Measures

    1. Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score [Baseline, 12 weeks]

      Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.

    2. Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale [Baseline, 12 weeks]

      Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.

    3. Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale [Baseline, 12 weeks]

      Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.

    4. Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale [Baseline, 12 weeks]

      Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.

    5. Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale [Baseline, 12 weeks]

      Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.

    6. Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) [Baseline, 12 weeks]

      Single-item clinician rating of the clinician's assessment of the patient's severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7.

    7. Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score [Baseline, 12 weeks]

      30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54.

    8. Endpoint Scores in Patient Global Impression - Improvement (PGI-I) [Baseline, 12 weeks]

      7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse).

    9. Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS) [Baseline, 12 weeks]

      Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms.

    10. Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI) [Baseline, 12 weeks]

      21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63.

    11. Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score [Baseline, 12 weeks]

      AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores.

    12. Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol [Baseline, 12 weeks]

      Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed.

    13. Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine [Baseline, 12 weeks]

      Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.

    14. Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs [Baseline, 12 weeks]

      Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year.

    15. Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine [Baseline, 12 weeks]

      Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.

    16. Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana [Baseline, 12 weeks]

      Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed.

    17. Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND) [Baseline, 12 weeks]

      The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).

    18. Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS) [Baseline, 12 weeks]

      Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60.

    19. Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report [Baseline, 12 weeks]

      26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104.

    20. Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report [Baseline, 12 weeks]

      26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104.

    21. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score [Baseline, 12 weeks]

      The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90.

    22. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score [Baseline, 12 weeks]

      The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.

    23. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score [Baseline, 12 weeks]

      The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225.

    24. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section [Baseline, 12 weeks]

      The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20.

    25. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section [Baseline, 12 weeks]

      Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5.

    26. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section [Baseline, 12 weeks]

      The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.

    27. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section [Baseline, 12 weeks]

      The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.

    28. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section [Baseline, 12 weeks]

      BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120.

    29. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section [Baseline, 12 weeks]

      The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10.

    30. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section [Baseline, 12 weeks]

      The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.

    31. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section [Baseline, 12 weeks]

      The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.

    32. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section [Baseline, 12 weeks]

      The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.

    33. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section [Baseline, 12 weeks]

      The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.

    34. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section [Baseline, 12 weeks]

      The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.

    35. Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section [Baseline, 12 weeks]

      The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.

    36. Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS) [Baseline, 12 weeks]

      Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.

    37. Responders by Baseline Smoking Status [12 weeks]

      Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.

    38. Strong Responders by Baseline Smoking Status [12 weeks]

      Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least moderate severity

    • male or female 18 to 30 years of age

    • must be able to swallow capsules

    • must be able to communicate effectively in English

    • must not have cognitive impairment

    • be reliable to keep appointments for clinic visits and all related tests

    Exclusion Criteria:

    • patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis

    • females who are pregnant or breastfeeding

    • patients with dementia or traumatic brain injury

    • patients with a history of severe allergy to atomoxetine

    • have untreated hypertension or thyroid problem

    • have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Los Angeles California United States 90024
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rolling Hills Est. California United States 90274
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Spring Valley California United States 91978
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wildomar California United States 92595
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Gainesville Florida United States 32607
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Jacksonville Florida United States 32216
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. South Miami Florida United States 33143
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. St. Petersburg Florida United States 33709
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Eagle Idaho United States 83616
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Topeka Kansas United States 66606
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Lexington Kentucky United States 40509
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Belmont Massachusetts United States 02478
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Farmington Hills Michigan United States 48336
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Omaha Nebraska United States 68198
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Las Vegas Nevada United States 89128
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Piscataway New Jersey United States 08854
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10010
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charlotte North Carolina United States 28211
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Beachwood Ohio United States 44122
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Cincinnati Ohio United States 45267
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oklahoma City Oklahoma United States 73103
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Charleston South Carolina United States 29405
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Burlington Vermont United States 05401
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Woodstock Vermont United States 05091
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Midlothian Virginia United States 23112
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Seattle Washington United States 98104
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Spokane Washington United States 99202
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Hato Rey Puerto Rico 00918
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Juan Puerto Rico 00907

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00510276
    Other Study ID Numbers:
    • 10803
    • B4Z-US-LYDZ
    First Posted:
    Aug 1, 2007
    Last Update Posted:
    Apr 14, 2010
    Last Verified:
    Apr 1, 2010
    Additional relevant MeSH terms:
    Hyperkinesis
    Attention Deficit Disorder with Hyperactivity
    Atomoxetine Hydrochloride

    Study Results

    Participant Flow

    Recruitment Details The recruitment period was from 16 August 2007 until 19 August 2008 in medical clinics.
    Pre-assignment Detail Study Period 1 was a screening/washout period. Subjects who did not meet enrollment criteria were excluded from the trial before randomization. 584 participants entered the screening phase, 139 were screen failures. There was an optional 12-week open-label atomoxetine extension phase after the 12-week acute double-blind phase.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Period Title: Acute Double-Blind Phase
    STARTED 220 225
    COMPLETED 115 130
    NOT COMPLETED 105 95
    Period Title: Acute Double-Blind Phase
    STARTED 111 129
    COMPLETED 78 81
    NOT COMPLETED 33 48

    Baseline Characteristics

    Arm/Group Title Atomoxetine Placebo Total
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks Total of all reporting groups
    Overall Participants 220 225 445
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    24.71
    (3.35)
    24.68
    (3.48)
    24.69
    (3.42)
    Sex: Female, Male (Count of Participants)
    Female
    92
    41.8%
    98
    43.6%
    190
    42.7%
    Male
    128
    58.2%
    127
    56.4%
    255
    57.3%
    Region of Enrollment (participants) [Number]
    United States
    210
    95.5%
    220
    97.8%
    430
    96.6%
    Puerto Rico
    10
    4.5%
    5
    2.2%
    15
    3.4%
    Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Life Outlook Subscale (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    54.40
    (15.42)
    52.49
    (15.41)
    53.44
    (15.43)
    Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Psychological Health Subscale (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    49.89
    (18.95)
    50.98
    (18.20)
    50.44
    (18.56)
    Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    45.95
    (13.74)
    45.30
    (13.53)
    45.62
    (13.62)
    Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - relationship subscale (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    52.76
    (19.35)
    52.47
    (19.67)
    52.61
    (19.49)
    Beck Anxiety Inventory (BAI) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    10.98
    (9.69)
    9.18
    (8.47)
    10.07
    (9.13)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Behavioral Regulation (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    62.40
    (11.91)
    60.94
    (10.77)
    61.66
    (11.36)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Emotional Control (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    18.76
    (5.73)
    18.22
    (5.33)
    18.49
    (5.53)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - GEC (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    157.11
    (22.80)
    156.12
    (21.00)
    156.61
    (21.89)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Inconsistency (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    3.22
    (1.86)
    3.50
    (1.97)
    3.36
    (1.92)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Infrequency (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    0.13
    (0.40)
    0.15
    (0.38)
    0.14
    (0.39)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Inhibit (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    18.28
    (2.77)
    18.11
    (2.72)
    18.19
    (2.74)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Initiate (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    18.33
    (3.11)
    18.32
    (3.00)
    18.33
    (3.05)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Metacognition Index (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    94.71
    (13.69)
    95.18
    (12.77)
    94.95
    (13.22)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Negativity (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    2.22
    (2.16)
    2.06
    (2.03)
    2.14
    (2.10)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Plan/Organize (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    23.25
    (4.02)
    23.31
    (3.91)
    23.28
    (3.96)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - SHIFT (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    12.56
    (2.82)
    12.36
    (2.64)
    12.46
    (2.73)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Self Monitor (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    12.80
    (3.01)
    12.25
    (2.89)
    12.52
    (2.96)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Task Monitor (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    14.44
    (2.36)
    14.68
    (2.31)
    14.56
    (2.33)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report - Working Memory (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    19.87
    (2.73)
    19.87
    (2.69)
    19.87
    (2.71)
    Behavior Rating Inventory of Executive Function-Adult Version Self Report- Organization of Materials (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    18.82
    (4.07)
    19.00
    (3.87)
    18.91
    (3.97)
    Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    4.79
    (0.66)
    4.68
    (0.64)
    4.74
    (0.65)
    Conners' ADHD Rating Scale Self Report (CAARS-S:SV) Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    35.01
    (8.97)
    35.69
    (8.60)
    35.36
    (8.78)
    Conners' Adult ADHD Rating Scale - Investigator Rated:Screening Version Total Score (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    39.15
    (7.48)
    38.95
    (7.72)
    39.05
    (7.59)
    Driving Behavior Survey Self-Report (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    79.86
    (12.89)
    78.95
    (12.46)
    79.41
    (12.67)
    Driving Behavior Survey-Other Report (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    70.90
    (10.13)
    78.00
    (11.24)
    74.77
    (11.21)
    Epworth Sleepiness Scale (ESS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    9.82
    (4.71)
    9.60
    (4.74)
    9.71
    (4.72)
    Fagerstrom Test for Nicotine Dependence (FTND) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    2.08
    (2.10)
    2.33
    (2.22)
    2.20
    (2.16)
    Habits Timeline Followback (TLFB) Incidence for Use of Alcohol (number of alcoholic drinks per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [number of alcoholic drinks per day]
    0.98
    (1.33)
    1.08
    (1.44)
    1.03
    (1.38)
    Habits Timeline Followback (TLFB) Incidence for Use of Caffeine (number of caffeinated drinks per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [number of caffeinated drinks per day]
    1.78
    (1.72)
    1.87
    (3.19)
    1.82
    (2.55)
    Habits Timeline Followback (TLFB) Incidence for Use of Drugs (ratio) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ratio]
    0.13
    (0.15)
    0.27
    (0.37)
    0.18
    (0.24)
    Habits Timeline Followback (TLFB) Incidence for Use of Marijuana (number of joints smoked per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [number of joints smoked per day]
    0.39
    (0.59)
    0.28
    (0.38)
    0.34
    (0.50)
    Habits Timeline Followback (TLFB) Incidence for Use of Nicotine (number of nicotine-products used per day) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [number of nicotine-products used per day]
    6.91
    (7.73)
    6.41
    (7.44)
    6.65
    (7.57)
    Montgomery Asberg Depression Rating Scale (MADRS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    6.68
    (4.28)
    6.29
    (4.01)
    6.48
    (4.14)
    Social Adaptation Self-Evaluation Scale (SASS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    36.99
    (6.17)
    37.28
    (5.93)
    37.14
    (6.04)

    Outcome Measures

    1. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score
    Description Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 117 131
    Least Squares Mean (Standard Error) [units on a scale]
    15.76
    (1.28)
    10.95
    (1.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments A gate-keeper strategy was applied to adjust for multiple tests.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.82
    Confidence Interval (2-Sided) 95%
    1.44 to 8.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale
    Description Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale asseses quality of relationships. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population was used for analysis. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 117 131
    Least Squares Mean (Standard Error) [units on a scale]
    15.51
    (1.60)
    9.61
    (1.54)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments A gate-keeper strategy was applied to adjust for multiple tests.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.90
    Confidence Interval (2-Sided) 95%
    1.68 to 10.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale
    Description Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses life productivity. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 117 131
    Least Squares Mean (Standard Error) [units on a scale]
    20.92
    (1.79)
    15.18
    (1.72)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 relationship subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments A gate-keeper strategy was applied to adjust for multiple tests.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 5.73
    Confidence Interval (2-Sided) 95%
    1.00 to 10.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale
    Description Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses the psychological health. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 117 131
    Least Squares Mean (Standard Error) [units on a scale]
    14.57
    (1.53)
    10.21
    (1.47)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 psychological health subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments A gate-keeper strategy was applied to adjust for multiple tests.
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 4.36
    Confidence Interval (2-Sided) 95%
    0.33 to 8.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale
    Description Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale asseses life outlook. Individual items are scored on a five-point Likert-like scale from "not at all/never=1" to "extremely/very often=5". The range of scores for this subscale is 0 to 100. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    An intent-to-treat population was analyzed. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 117 131
    Least Squares Mean (Standard Error) [units on a scale]
    9.27
    (1.40)
    5.87
    (1.33)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in AAQOL-29 life outlook subscale score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.074
    Comments A gate-keeper strategy was applied to adjust for multiple tests.
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 3.40
    Confidence Interval (2-Sided) 95%
    -0.33 to 7.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)
    Description Single-item clinician rating of the clinician's assessment of the patient's severity of the ADHD symptoms in relation to the clinician's total experience with ADHD patients. Severity is rated on a 7-point scale (1 = normal, not at all ill; 7 = among the most extremely ill patients). The total score ranges from 1 to 7.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 192 200
    Least Squares Mean (Standard Error) [units on a scale]
    -1.10
    (0.08)
    -0.67
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in CGI-ADHD-S score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments ANCOVA with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.43
    Confidence Interval (2-Sided) 95%
    -0.63 to -0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    7. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score
    Description 30-item patient-reported scale with 3 subscales: Inattention subscale, Hyperactivity-Impulsivity subscale, and ADHD Index. 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each individual item is scored on a 0 to 3 scale (0 = not at all, never; 1 = just a little, once in a while; 2 = Pretty much, often; 3 = very much, very frequently). The rating scale assesses symptom severity over the past week. The total score ranges from 0 to 54.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    An intent-to-treat population was analyzed using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 189 197
    Least Squares Mean (Standard Error) [units on a scale]
    -11.88
    (0.75)
    -7.84
    (0.73)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in CAARS-S:SV score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -4.04
    Confidence Interval (2-Sided) 95%
    -5.94 to -2.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    8. Secondary Outcome
    Title Endpoint Scores in Patient Global Impression - Improvement (PGI-I)
    Description 7-point scale modeled after the CGI on which patients rate any change in their overall status that they had experienced since beginning the study drug. The score on this scale ranges from 1 (very much improved) to 7 (very much worse).
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 189 197
    Least Squares Mean (Standard Error) [units on a scale]
    3.17
    (0.08)
    3.42
    (0.08)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in PGI-I scores at 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.020
    Comments
    Method ANCOVA
    Comments ANCOVA with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.25
    Confidence Interval (2-Sided) 95%
    -0.45 to -0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)
    Description Rating scale for severity of depressive mood symptoms, administered by the investigator. The scale consists of 10 items, each rated on a scale from 0 to 6. The MADRS total score is the sum of the 10 items and the score ranges from 0 to 60. Higher scores denote more severe depressive symptoms.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 173 177
    Least Squares Mean (Standard Error) [units on a scale]
    -0.72
    (0.30)
    -0.30
    (0.30)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in MADRS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.282
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.42
    Confidence Interval (2-Sided) 95%
    -1.19 to 0.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)
    Description 21-item self-reported screening tool for measuring anxiety severity. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely; I could barely stand it). Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. Patients record how much they have been bothered by each symptom during the past week, including the day the questionnaire is administered. The total score ranges from 0 to 63.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 151 156
    Least Squares Mean (Standard Error) [units on a scale]
    -2.58
    (0.66)
    -2.07
    (0.66)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BAI score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.556
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.51
    Confidence Interval (2-Sided) 95%
    -2.21 to 1.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    11. Secondary Outcome
    Title Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score
    Description AAQOL-29: Patient-reported outcome measure examining disease-specific functional impariments and quality of life for adults with ADHD. The domains included in the AAQOL are life productivity, psychological health, quality of relationships, and life outlook. Consistent with the majority of existing quality of life measures, higher scores on the AAQOL-29 indicate better functioning. CAARS-Inv:SV: Inattention subscale, Impulsivity subscale, and ADHD Index. Each item is scored on a 0 to 3 scale, assessing symptom severity over the past week. The total score is the sum of all subscale scores.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine 20 - 50 mg BID and Placebo
    Arm/Group Description
    Measure Participants 378
    Number [correlation coefficient]
    -0.591
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine
    Comments Tested was the null hypothesis that AAQOL-29 total score and CAARS-Inv:SV total score are not correlated.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Pearson's Correlation Coefficient
    Comments
    12. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol
    Description Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of standard drinks that have been consumed.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 119 121
    Least Squares Mean (Standard Error) [number of alcoholic drinks per day]
    -0.21
    (0.09)
    -0.06
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of alcohol score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.198
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.15
    Confidence Interval (2-Sided) 95%
    -0.39 to 0.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    13. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine
    Description Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of caffeine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 162 163
    Least Squares Mean (Standard Error) [number of caffeinated drinks per day]
    -0.23
    (0.11)
    -0.20
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of caffeine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.825
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.03
    Confidence Interval (2-Sided) 95%
    -0.33 to 0.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs
    Description Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of recreational drugs other than marijuana an individual consumed and is expressed as the ratio of number of days on which drugs were used over the total number of days, resulting in a total score ranging from 0 to 1. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 2 2
    Mean (Standard Deviation) [ratio]
    0.02
    (0.01)
    0.02
    (0.23)
    15. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine
    Description Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. This subscale assesses the amount of nicotine consumed by an individual. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 70 70
    Least Squares Mean (Standard Error) [number of nicotine products per day]
    0.01
    (0.51)
    -0.81
    (0.52)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of nicotine score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.233
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.82
    Confidence Interval (2-Sided) 95%
    -0.53 to 2.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana
    Description Variation of the Alcohol Timeline Followback (TLFB) which is a method for assessing the quantity of alcohol consumption on a daily basis. With a calendar as a guide, the interviewee provides a retrospective estimate of daily habits over a specified period of as long as the previous year. The goal is to provide a detailed record of patterns of use that can be used to guide treatment and to assess treatment outcome. Recorded is the number of joints that have been consumed.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 26 20
    Least Squares Mean (Standard Error) [number of joints per day]
    0.09
    (0.10)
    0.03
    (0.12)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in TLFB incidence for use of marijuana score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.676
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.06
    Confidence Interval (2-Sided) 95%
    -0.24 to 0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)
    Description The FTND was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The FTND contains 4 yes-no and 2 multiple choice questions and can be used in a self-report format. The items on FTND are scored 0 to 3 for multiple choice items, the items are summed to yield a total score of 0-10 (0=minimum nicotine dependence; 10=maximum nicotine dependence).
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 48 42
    Least Squares Mean (Standard Error) [units on a scale]
    0.12
    (0.25)
    0.43
    (0.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in Fagerstorm Test for Nicotine Dependence score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.382
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.31
    Confidence Interval (2-Sided) 95%
    -1.00 to 0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)
    Description Patient completed scale that consists of 21 items that examine behavior and subjective perception, including satisfaction, self-perception and motivation in participating in and maintaining relationships with family and friends, satisfaction in work, home and leisure activities, and intellectual interests. Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range from 0 to 60.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was a intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 165
    Least Squares Mean (Standard Error) [units on a scale]
    1.24
    (0.39)
    1.46
    (0.39)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in SASS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.656
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.22
    Confidence Interval (2-Sided) 95%
    -1.24 to 0.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report
    Description 26 item self-rated driving survey with examples of driving behaviors, e.g.: putting on seat belt, driving within speed limits, yielding the right of way to other drivers. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items. A driving history is completed by self-report the first time a rater completes the Driving Behavior Survey (Self-Report). The total score ranges from 26 to 104.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward as imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 140 142
    Least Squares Mean (Standard Error) [units on a scale]
    1.93
    (0.98)
    3.54
    (1.01)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Self-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.201
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.61
    Confidence Interval (2-Sided) 95%
    -4.08 to 0.86
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    20. Primary Outcome
    Title Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint
    Description CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.
    Time Frame Baseline, Week 12

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population was analyzed, including all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 119 134
    Least Squares Mean (Standard Error) [units on a scale]
    -14.88
    (0.88)
    -9.82
    (0.85)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no difference in CAARS-Inv:SV score changes from baseline to 12-week endpoint between the atomoxetine group and the placebo group. With approximately 220 patients per arm, assuming a 68% completion rate and an estimated effect size of atomoxetine over placebo of 0.35, using a 5% significance level, the analysis was expected to have 90% power to detect a difference between atomoxetine and placebo at week 12.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments Adjusted for treatment, investigator, visit, treatment-by-visit interaction, baseline score, baseline score-by-visit interaction.
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -5.06
    Confidence Interval (2-Sided) 95%
    -7.39 to -2.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    21. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report
    Description 26-item driving survey completed by someone other than the patient/driver. Examples of driving behaviors included in the survey match those listed in the Self-Report version of the scale. Items are rated on a 4-point scale (1 = not at all or rarely, 2 = sometimes, 3 = often, 4 = very often). The total score is the sum of the 26 items and ranges from 26 to 104.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 13 11
    Least Squares Mean (Standard Error) [units on a scale]
    3.24
    (3.67)
    2.63
    (3.96)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in Driving Behavior Survey Other-Report score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.933
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.61
    Confidence Interval (2-Sided) 95%
    -16.41 to 17.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    22. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score
    Description The BRIEF-A behavioral regulation subscale measures an individuals control over behavior in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 30 to 90.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -8.15
    (0.83)
    -5.20
    (0.83)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Behavioral regulation score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -2.95
    Confidence Interval (2-Sided) 95%
    -5.09 to -0.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    23. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score
    Description The BRIEF-A emotional control subscale assesses an individuals emotional control in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -1.98
    (0.36)
    -1.40
    (0.36)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A emotional control section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.219
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.58
    Confidence Interval (2-Sided) 95%
    -1.50 to 0.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    24. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score
    Description The BRIEF-A GEC rates the global executive composite of the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 75 to 225.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -22.41
    (1.86)
    -14.83
    (1.85)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A GEC section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -7.58
    Confidence Interval (2-Sided) 95%
    -12.37 to -2.78
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    25. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section
    Description The BRIEF-A Inconsistency rates the behavioral inconsistency displayed by the patient in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 20.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -0.51
    (0.15)
    -0.42
    (0.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inconsistency section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.644
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.09
    Confidence Interval (2-Sided) 95%
    -0.47 to 0.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    26. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section
    Description Standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which respondent answers additional items in an unusual and infrequent direction. Form is designed to be completed by adults 18-90 years of age, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. Total score ranges from 0 to 5.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    0.27
    (0.05)
    0.16
    (0.05)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEFS-A infrequency score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.097
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 0.11
    Confidence Interval (2-Sided) 95%
    -0.02 to 0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    27. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section
    Description The BRIEF-A Inhibit rates an individual's inhibition in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -2.62
    (0.23)
    -1.65
    (0.23)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Inhibit Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -1.57 to -0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    28. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section
    Description The BRIEF-A Initiate rates an individual's initiative behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -2.41
    (0.25)
    -1.74
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Initiate section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.044
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.33 to -0.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    29. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section
    Description BRIEF-A Metacognition subscale is a standardized measure assessing individual's ability to systematically solve problems via planning and organization while sustaining these task-completion efforts in active working memory. Form is designed to be completed by adults, including adults with wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior never observed, 2=behavior sometimes observed, and 3=behavior often observed - higher ratings indicate greater perceived impairment. Total score ranges from 40 to 120.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -14.13
    (1.14)
    -9.64
    (1.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Metacognition section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -4.49
    Confidence Interval (2-Sided) 95%
    -7.43 to -1.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    30. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section
    Description The BRIEF-A Negativity asseses an indivduals' perceived negativity in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 0 to 10.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -0.85
    (0.14)
    -0.71
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A negativity section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.456
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.14
    Confidence Interval (2-Sided) 95%
    -0.51 to 0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    31. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section
    Description The BRIEF-A Organization of Materials assesses an individuals' organizing skills in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -2.50
    (0.25)
    -1.85
    (0.25)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Organization of Materials section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.051
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.65
    Confidence Interval (2-Sided) 95%
    -1.31 to 0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    32. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section
    Description The BRIEF-A Plan/Organize asseses an individuals' capabilities to plan and organize in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Behavior is rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 10 to 30.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -3.62
    (0.33)
    -2.28
    (0.33)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Plan/Organize section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.34
    Confidence Interval (2-Sided) 95%
    -2.19 to -0.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    33. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section
    Description The BRIEF-A Shift assess an individuals' shifting between different behaviors in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -1.49
    (0.20)
    -0.96
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A SHIFT section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.53
    Confidence Interval (2-Sided) 95%
    -1.04 to -0.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    34. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section
    Description The BRIEF-A Self Monitor assesses an individuals' capacity to self monitor in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -2.03
    (0.20)
    -1.20
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Self Monitor Section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.83
    Confidence Interval (2-Sided) 95%
    -1.35 to -0.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    35. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section
    Description The BRIEF-A Task Monitor assesses an individuals's ability to monitor a task in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 6 to 18.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -2.28
    (0.20)
    -1.57
    (0.20)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Task Monitor section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.71
    Confidence Interval (2-Sided) 95%
    -1.23 to -0.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    36. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section
    Description The BRIEF-A Working Memory assesses an individuals' memory function in his or her everyday environment. The self-report form is designed to be completed by adults 18-90 years of age, including adults with a wide variety of developmental, systemic, neurological, and psychiatric disorders. Observations are rated on a 3-point Likert scale, with 1=behavior is never observed, 2=behavior is sometimes observed, and 3=behavior is often observed - higher ratings indicate greater perceived impairment. The total score ranges from 8 to 24.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 161 167
    Least Squares Mean (Standard Error) [units on a scale]
    -3.48
    (0.26)
    -2.18
    (0.26)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in BRIEF-A Working Memory section score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -1.3
    Confidence Interval (2-Sided) 95%
    -1.98 to -0.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    37. Secondary Outcome
    Title Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)
    Description Used to determine the level of daytime sleepiness. The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities. Subjects rate the likelihood of dozing off or falling asleep in each of these situations. Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing). The item scores are summed to produce a total score (range of 0-24). Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.
    Time Frame Baseline, 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    Measure Participants 187 196
    Least Squares Mean (Standard Error) [units on a scale]
    -1.76
    (0.29)
    -1.07
    (0.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo
    Comments Tested was the null hypothesis that there is no statistically significant difference in ESS score changes from baseline to 12-week endpoint between atomoxetine and placebo treatment groups.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.065
    Comments
    Method ANCOVA
    Comments ANCOVA model with terms for baseline score, treatment, and investigator
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -1.42 to 0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    38. Secondary Outcome
    Title Responders by Baseline Smoking Status
    Description Baseline smoking status was recorded and associations to response to treatment were determined. Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine 20 - 50 mg BID, Smokers Atomoxetine 20 - 50 mg BID, Non-smokers Placebo, Smokers Placebo Non-smokers
    Arm/Group Description
    Measure Participants 91 128 94 131
    Number [participants]
    54
    24.5%
    60
    26.7%
    29
    6.5%
    53
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo, Placebo, Smokers, Placebo Non-smokers
    Comments Tested was the null hypothesis that smoking status is not a predictor of response to atomoxetine treatment compared with placebo
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.788
    Comments
    Method Cochran-Mantel-Haenszel
    Comments Tested was smoking status across treatment.
    39. Secondary Outcome
    Title Strong Responders by Baseline Smoking Status
    Description Baseline smoking status was recorded and associations to response to treatment were determined. Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score. The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Analyzed was an intent-to-treat population using last observation carried forward imputation technique. Included were all randomized patients who had both a baseline and at least 1 post baseline score.
    Arm/Group Title Atomoxetine 20 - 50 mg BID, Smokers Atomoxetine 20 - 50 mg BID, Non-Smokers Placebo, Smokers Placebo, Non-Smokers
    Arm/Group Description
    Measure Participants 91 128 94 131
    Number [participants]
    38
    17.3%
    41
    18.2%
    19
    4.3%
    31
    NaN
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Atomoxetine, Placebo, Placebo, Smokers, Placebo Non-smokers
    Comments Tested was the null hypothesis that smoking status is not a predictor of strong response to atomoxetine treatment compared with placebo
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.482
    Comments Tested was smoking status across treatment.
    Method Cochran-Mantel-Haenszel
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Atomoxetine Placebo
    Arm/Group Description 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks twice a day for 12 weeks
    All Cause Mortality
    Atomoxetine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Atomoxetine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/220 (0.5%) 1/225 (0.4%)
    Gastrointestinal disorders
    Colitis 1/220 (0.5%) 1 0/225 (0%) 0
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/220 (0%) 0 1/225 (0.4%) 1
    Other (Not Including Serious) Adverse Events
    Atomoxetine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 147/220 (66.8%) 121/225 (53.8%)
    Gastrointestinal disorders
    Abdominal discomfort 6/220 (2.7%) 6 2/225 (0.9%) 2
    Constipation 6/220 (2.7%) 6 1/225 (0.4%) 1
    Diarrhoea 3/220 (1.4%) 3 5/225 (2.2%) 5
    Dry mouth 19/220 (8.6%) 19 5/225 (2.2%) 5
    Dyspepsia 11/220 (5%) 12 2/225 (0.9%) 2
    Nausea 31/220 (14.1%) 35 11/225 (4.9%) 11
    Vomiting 7/220 (3.2%) 7 7/225 (3.1%) 7
    General disorders
    Fatigue 13/220 (5.9%) 13 13/225 (5.8%) 14
    Irritability 12/220 (5.5%) 13 4/225 (1.8%) 4
    Infections and infestations
    Nasopharyngitis 6/220 (2.7%) 6 10/225 (4.4%) 10
    Pharyngitis streptococcal 5/220 (2.3%) 5 1/225 (0.4%) 1
    Upper respiratory tract infection 10/220 (4.5%) 10 13/225 (5.8%) 13
    Investigations
    Weight decreased 7/220 (3.2%) 7 2/225 (0.9%) 2
    Metabolism and nutrition disorders
    Decreased appetite 27/220 (12.3%) 27 5/225 (2.2%) 5
    Nervous system disorders
    Dizziness 11/220 (5%) 11 3/225 (1.3%) 3
    Headache 13/220 (5.9%) 15 18/225 (8%) 19
    Sedation 6/220 (2.7%) 7 3/225 (1.3%) 3
    Somnolence 10/220 (4.5%) 10 4/225 (1.8%) 4
    Psychiatric disorders
    Abnormal dreams 6/220 (2.7%) 6 8/225 (3.6%) 8
    Anxiety 9/220 (4.1%) 10 5/225 (2.2%) 5
    Insomnia 23/220 (10.5%) 23 10/225 (4.4%) 10
    Reproductive system and breast disorders
    Erectile dysfunction 5/220 (2.3%) 5 0/225 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 1/220 (0.5%) 1 5/225 (2.2%) 5

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00510276
    Other Study ID Numbers:
    • 10803
    • B4Z-US-LYDZ
    First Posted:
    Aug 1, 2007
    Last Update Posted:
    Apr 14, 2010
    Last Verified:
    Apr 1, 2010