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

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ClinicalTrials.gov Identifier: NCT00510276
Recruitment Status : Completed
First Posted : August 1, 2007
Results First Posted : March 3, 2010
Last Update Posted : April 14, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: Atomoxetine hydrochloride
Drug: Placebo
Enrollment 445
Recruitment Details The recruitment period was from 16 August 2007 until 19 August 2008 in medical clinics.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Adverse Event             21             6
Entry Criteria Not Met             1             1
Lack of Efficacy             3             4
Lost to Follow-up             48             49
Physician Decision             0             3
Protocol Violation             4             3
Sponsor Decision             2             1
Subject Decision             26             28
Period Title: Extension Open-Label Phase
Started 111 [1] 129 [2]
Completed 78 81
Not Completed 33 48
Reason Not Completed
Adverse Event             9             18
Lack of Efficacy             2             7
Lost to Follow-up             12             10
Physician Decision             2             3
Protocol Violation             0             1
Sponsor Decision             1             0
Subject Decision             7             9
[1]
4 patients who completed acute phase did not participate in the optional atomoxetine extension phase
[2]
1 patient who completed acute phase did not participate in the optional atometine extension phase
Arm/Group Title Atomoxetine Placebo Total
Hide 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 Number of Baseline Participants 220 225 445
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 220 participants 225 participants 445 participants
24.71  (3.35) 24.68  (3.48) 24.69  (3.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 220 participants 225 participants 445 participants
Female
92
  41.8%
98
  43.6%
190
  42.7%
Male
128
  58.2%
127
  56.4%
255
  57.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 220 participants 225 participants 445 participants
United States 210 220 430
Puerto Rico 10 5 15
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Life Outlook Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
54.40  (15.42) 52.49  (15.41) 53.44  (15.43)
[1]
Measure 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 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.
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Psychological Health Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
49.89  (18.95) 50.98  (18.20) 50.44  (18.56)
[1]
Measure Description: Patient-reported outcome measure used to examine the disease specific functional impairments and quality of life for adults with ADHD. This subscale assesses 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.
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
45.95  (13.74) 45.30  (13.53) 45.62  (13.62)
[1]
Measure 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.
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - relationship subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
52.76  (19.35) 52.47  (19.67) 52.61  (19.49)
[1]
Measure Description: Patient-reported outcome measure used to examine the disease-specific functional impariments and quality of life for adults with ADHD. This subscale assesses 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.
Beck Anxiety Inventory (BAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
10.98  (9.69) 9.18  (8.47) 10.07  (9.13)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Behavioral Regulation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
62.40  (11.91) 60.94  (10.77) 61.66  (11.36)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Emotional Control   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
18.76  (5.73) 18.22  (5.33) 18.49  (5.53)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - GEC   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
157.11  (22.80) 156.12  (21.00) 156.61  (21.89)
[1]
Measure Description: The BRIEF-A Global Executive Composite (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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Inconsistency   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
3.22  (1.86) 3.50  (1.97) 3.36  (1.92)
[1]
Measure 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. 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 is calculated based on a weighted secondary scoring system and ranges from 0 to 20.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Infrequency   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
0.13  (0.40) 0.15  (0.38) 0.14  (0.39)
[1]
Measure Description: BRIEF-A Infrequency is a standardized measure assessing adult executive functioning/self-regulation in his/her everyday environment. Extent to which the respondent answers additional items in an unusual and infrequent direction. Self-report form is designed to be completed by adults 18-90 years of age. 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. Total score is calculated based on weighted secondary scoring system and ranges from 0 to 5.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Inhibit   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
18.28  (2.77) 18.11  (2.72) 18.19  (2.74)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Initiate   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
18.33  (3.11) 18.32  (3.00) 18.33  (3.05)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Metacognition Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
94.71  (13.69) 95.18  (12.77) 94.95  (13.22)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Negativity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
2.22  (2.16) 2.06  (2.03) 2.14  (2.10)
[1]
Measure 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 is calculated based on a weighted secondary scoring system and ranges from 0 to 10.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Plan/Organize   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
23.25  (4.02) 23.31  (3.91) 23.28  (3.96)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - SHIFT   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
12.56  (2.82) 12.36  (2.64) 12.46  (2.73)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Self Monitor   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
12.80  (3.01) 12.25  (2.89) 12.52  (2.96)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Task Monitor   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
14.44  (2.36) 14.68  (2.31) 14.56  (2.33)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Working Memory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
19.87  (2.73) 19.87  (2.69) 19.87  (2.71)
[1]
Measure 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.
Behavior Rating Inventory of Executive Function-Adult Version Self Report- Organization of Materials   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
18.82  (4.07) 19.00  (3.87) 18.91  (3.97)
[1]
Measure 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.
Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
4.79  (0.66) 4.68  (0.64) 4.74  (0.65)
[1]
Measure 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.
Conners' ADHD Rating Scale Self Report (CAARS-S:SV) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
35.01  (8.97) 35.69  (8.60) 35.36  (8.78)
[1]
Measure Description: The CAARS-S:SV is a 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.
Conners' Adult ADHD Rating Scale - Investigator Rated:Screening Version Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
39.15  (7.48) 38.95  (7.72) 39.05  (7.59)
[1]
Measure 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.
Driving Behavior Survey Self-Report   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
79.86  (12.89) 78.95  (12.46) 79.41  (12.67)
[1]
Measure 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.
Driving Behavior Survey-Other Report   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
70.90  (10.13) 78.00  (11.24) 74.77  (11.21)
[1]
Measure 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.
Epworth Sleepiness Scale (ESS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
9.82  (4.71) 9.60  (4.74) 9.71  (4.72)
[1]
Measure 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.
Fagerstrom Test for Nicotine Dependence (FTND)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
2.08  (2.10) 2.33  (2.22) 2.20  (2.16)
[1]
Measure 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).
Habits Timeline Followback (TLFB) Incidence for Use of Alcohol   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of alcoholic drinks per day
Number Analyzed 220 participants 225 participants 445 participants
0.98  (1.33) 1.08  (1.44) 1.03  (1.38)
[1]
Measure 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.
Habits Timeline Followback (TLFB) Incidence for Use of Caffeine   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of caffeinated drinks per day
Number Analyzed 220 participants 225 participants 445 participants
1.78  (1.72) 1.87  (3.19) 1.82  (2.55)
[1]
Measure 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.
Habits Timeline Followback (TLFB) Incidence for Use of Drugs   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 220 participants 225 participants 445 participants
0.13  (0.15) 0.27  (0.37) 0.18  (0.24)
[1]
Measure 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.
Habits Timeline Followback (TLFB) Incidence for Use of Marijuana   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of joints smoked per day
Number Analyzed 220 participants 225 participants 445 participants
0.39  (0.59) 0.28  (0.38) 0.34  (0.50)
[1]
Measure 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 marjuana 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. Recorded is the number of joints that have been consumed.
Habits Timeline Followback (TLFB) Incidence for Use of Nicotine   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of nicotine-products used per day
Number Analyzed 220 participants 225 participants 445 participants
6.91  (7.73) 6.41  (7.44) 6.65  (7.57)
[1]
Measure 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.
Montgomery Asberg Depression Rating Scale (MADRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
6.68  (4.28) 6.29  (4.01) 6.48  (4.14)
[1]
Measure 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.
Social Adaptation Self-Evaluation Scale (SASS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 220 participants 225 participants 445 participants
36.99  (6.17) 37.28  (5.93) 37.14  (6.04)
[1]
Measure Description: The SASS is a 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.
1.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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 119 134
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.88  (0.88) -9.82  (0.85)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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) Total Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 117 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
15.76  (1.28) 10.95  (1.23)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.82
Confidence Interval (2-Sided) 95%
1.44 to 8.20
Estimation Comments [Not Specified]
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) Relationship Subscale
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 117 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
15.51  (1.60) 9.61  (1.54)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.90
Confidence Interval (2-Sided) 95%
1.68 to 10.12
Estimation Comments [Not Specified]
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) Life Productivity Subscale
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 117 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
20.92  (1.79) 15.18  (1.72)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.73
Confidence Interval (2-Sided) 95%
1.00 to 10.46
Estimation Comments [Not Specified]
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) Psychological Health Subscale
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 117 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
14.57  (1.53) 10.21  (1.47)
Show Statistical Analysis 1 Hide 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 [Not Specified]
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 [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.36
Confidence Interval (2-Sided) 95%
0.33 to 8.39
Estimation Comments [Not Specified]
6.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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 117 131
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
9.27  (1.40) 5.87  (1.33)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments A gate-keeper strategy was applied to adjust for multiple tests.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.40
Confidence Interval (2-Sided) 95%
-0.33 to 7.12
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 192 200
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.10  (0.08) -0.67  (0.08)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 189 197
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.88  (0.75) -7.84  (0.73)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.04
Confidence Interval (2-Sided) 95%
-5.94 to -2.15
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Endpoint Scores in Patient Global Impression - Improvement (PGI-I)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 189 197
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.17  (0.08) 3.42  (0.08)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
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
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 173 177
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.72  (0.30) -0.30  (0.30)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.282
Comments [Not Specified]
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
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 151 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.58  (0.66) -2.07  (0.66)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
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
Estimation Comments [Not Specified]
12.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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: correlation coefficient
-0.591
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 20 - 50 mg BID and Placebo
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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Pearson's Correlation Coefficient
Comments [Not Specified]
13.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 119 121
Least Squares Mean (Standard Error)
Unit of Measure: number of alcoholic drinks per day
-0.21  (0.09) -0.06  (0.09)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
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
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 162 163
Least Squares Mean (Standard Error)
Unit of Measure: number of caffeinated drinks per day
-0.23  (0.11) -0.20  (0.11)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.825
Comments [Not Specified]
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
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: ratio
0.02  (0.01) 0.02  (0.23)
16.Secondary Outcome
Title Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 70 70
Least Squares Mean (Standard Error)
Unit of Measure: number of nicotine products per day
0.01  (0.51) -0.81  (0.52)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments [Not Specified]
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
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 26 20
Least Squares Mean (Standard Error)
Unit of Measure: number of joints per day
0.09  (0.10) 0.03  (0.12)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.676
Comments [Not Specified]
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
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 48 42
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.12  (0.25) 0.43  (0.27)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.382
Comments [Not Specified]
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
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 165
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.24  (0.39) 1.46  (0.39)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments [Not Specified]
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
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 140 142
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.93  (0.98) 3.54  (1.01)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.201
Comments [Not Specified]
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
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 13 11
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.24  (3.67) 2.63  (3.96)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.933
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.15  (0.83) -5.20  (0.83)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.98  (0.36) -1.40  (0.36)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-22.41  (1.86) -14.83  (1.85)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.51  (0.15) -0.42  (0.15)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.27  (0.05) 0.16  (0.05)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.62  (0.23) -1.65  (0.23)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.41  (0.25) -1.74  (0.25)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-14.13  (1.14) -9.64  (1.13)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.85  (0.14) -0.71  (0.14)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.456
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.50  (0.25) -1.85  (0.25)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.62  (0.33) -2.28  (0.33)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.49  (0.20) -0.96  (0.20)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.03  (0.20) -1.20  (0.20)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.28  (0.20) -1.57  (0.20)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
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
Estimation Comments [Not Specified]
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 161 167
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.48  (0.26) -2.18  (0.26)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 187 196
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.76  (0.29) -1.07  (0.28)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
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
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Responders by Baseline Smoking Status
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 91 128 94 131
Measure Type: Number
Unit of Measure: participants
54 60 29 53
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 20 - 50 mg BID, Smokers, Atomoxetine 20 - 50 mg BID, Non-smokers, 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.788
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Tested was smoking status across treatment.
39.Secondary Outcome
Title Strong Responders by Baseline Smoking Status
Hide 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
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 91 128 94 131
Measure Type: Number
Unit of Measure: participants
38 41 19 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atomoxetine 20 - 50 mg BID, Smokers, Atomoxetine 20 - 50 mg BID, Non-Smokers, 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 [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments Tested was smoking status across treatment.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/220 (0.45%)      1/225 (0.44%)    
Gastrointestinal disorders     
Colitis  1  1/220 (0.45%)  1 0/225 (0.00%)  0
Injury, poisoning and procedural complications     
Alcohol poisoning  1  0/220 (0.00%)  0 1/225 (0.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Atomoxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   147/220 (66.82%)      121/225 (53.78%)    
Gastrointestinal disorders     
Abdominal discomfort  1  6/220 (2.73%)  6 2/225 (0.89%)  2
Constipation  1  6/220 (2.73%)  6 1/225 (0.44%)  1
Diarrhoea  1  3/220 (1.36%)  3 5/225 (2.22%)  5
Dry mouth  1  19/220 (8.64%)  19 5/225 (2.22%)  5
Dyspepsia  1  11/220 (5.00%)  12 2/225 (0.89%)  2
Nausea  1  31/220 (14.09%)  35 11/225 (4.89%)  11
Vomiting  1  7/220 (3.18%)  7 7/225 (3.11%)  7
General disorders     
Fatigue  1  13/220 (5.91%)  13 13/225 (5.78%)  14
Irritability  1  12/220 (5.45%)  13 4/225 (1.78%)  4
Infections and infestations     
Nasopharyngitis  1  6/220 (2.73%)  6 10/225 (4.44%)  10
Pharyngitis streptococcal  1  5/220 (2.27%)  5 1/225 (0.44%)  1
Upper respiratory tract infection  1  10/220 (4.55%)  10 13/225 (5.78%)  13
Investigations     
Weight decreased  1  7/220 (3.18%)  7 2/225 (0.89%)  2
Metabolism and nutrition disorders     
Decreased appetite  1  27/220 (12.27%)  27 5/225 (2.22%)  5
Nervous system disorders     
Dizziness  1  11/220 (5.00%)  11 3/225 (1.33%)  3
Headache  1  13/220 (5.91%)  15 18/225 (8.00%)  19
Sedation  1  6/220 (2.73%)  7 3/225 (1.33%)  3
Somnolence  1  10/220 (4.55%)  10 4/225 (1.78%)  4
Psychiatric disorders     
Abnormal dreams  1  6/220 (2.73%)  6 8/225 (3.56%)  8
Anxiety  1  9/220 (4.09%)  10 5/225 (2.22%)  5
Insomnia  1  23/220 (10.45%)  23 10/225 (4.44%)  10
Reproductive system and breast disorders     
Erectile dysfunction  1  5/220 (2.27%)  5 0/225 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/220 (0.45%)  1 5/225 (2.22%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00510276     History of Changes
Other Study ID Numbers: 10803
B4Z-US-LYDZ ( Other Identifier: Eli Lilly and Company )
First Submitted: July 30, 2007
First Posted: August 1, 2007
Results First Submitted: January 27, 2010
Results First Posted: March 3, 2010
Last Update Posted: April 14, 2010