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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00510276
First received: July 30, 2007
Last updated: April 7, 2010
Last verified: April 2010
Results First Received: January 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Atomoxetine hydrochloride
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment period was from 16 August 2007 until 19 August 2008 in medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Atomoxetine 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
Placebo twice a day for 12 weeks

Participant Flow for 2 periods

Period 1:   Acute Double-Blind Phase
    Atomoxetine     Placebo  
STARTED     220     225  
COMPLETED     115     130  
NOT COMPLETED     105     95  
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 2:   Extension Open-Label Phase
    Atomoxetine     Placebo  
STARTED     111 [1]   129 [2]
COMPLETED     78     81  
NOT COMPLETED     33     48  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Atomoxetine 20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
Placebo twice a day for 12 weeks
Total Total of all reporting groups

Baseline Measures
    Atomoxetine     Placebo     Total  
Number of Participants  
[units: participants]
  220     225     445  
Age  
[units: years]
Mean ± Standard Deviation
  24.71  ± 3.35     24.68  ± 3.48     24.69  ± 3.42  
Gender  
[units: participants]
     
Female     92     98     190  
Male     128     127     255  
Region of Enrollment  
[units: participants]
     
United States     210     220     430  
Puerto Rico     10     5     15  
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Life Outlook Subscale [1]
[units: units on a scale]
Mean ± Standard Deviation
  54.40  ± 15.42     52.49  ± 15.41     53.44  ± 15.43  
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Psychological Health Subscale [2]
[units: units on a scale]
Mean ± Standard Deviation
  49.89  ± 18.95     50.98  ± 18.20     50.44  ± 18.56  
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - Total Score [3]
[units: units on a scale]
Mean ± Standard Deviation
  45.95  ± 13.74     45.30  ± 13.53     45.62  ± 13.62  
Adult Attention-Deficit/Hyperactivity Disorder Quality of Life 29 - relationship subscale [4]
[units: units on a scale]
Mean ± Standard Deviation
  52.76  ± 19.35     52.47  ± 19.67     52.61  ± 19.49  
Beck Anxiety Inventory (BAI) [5]
[units: units on a scale]
Mean ± Standard Deviation
  10.98  ± 9.69     9.18  ± 8.47     10.07  ± 9.13  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Behavioral Regulation [6]
[units: units on a scale]
Mean ± Standard Deviation
  62.40  ± 11.91     60.94  ± 10.77     61.66  ± 11.36  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Emotional Control [7]
[units: units on a scale]
Mean ± Standard Deviation
  18.76  ± 5.73     18.22  ± 5.33     18.49  ± 5.53  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - GEC [8]
[units: units on a scale]
Mean ± Standard Deviation
  157.11  ± 22.80     156.12  ± 21.00     156.61  ± 21.89  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Inconsistency [9]
[units: units on a scale]
Mean ± Standard Deviation
  3.22  ± 1.86     3.50  ± 1.97     3.36  ± 1.92  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Infrequency [10]
[units: units on a scale]
Mean ± Standard Deviation
  0.13  ± 0.40     0.15  ± 0.38     0.14  ± 0.39  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Inhibit [11]
[units: units on a scale]
Mean ± Standard Deviation
  18.28  ± 2.77     18.11  ± 2.72     18.19  ± 2.74  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Initiate [12]
[units: units on a scale]
Mean ± Standard Deviation
  18.33  ± 3.11     18.32  ± 3.00     18.33  ± 3.05  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Metacognition Index [13]
[units: units on a scale]
Mean ± Standard Deviation
  94.71  ± 13.69     95.18  ± 12.77     94.95  ± 13.22  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Negativity [14]
[units: units on a scale]
Mean ± Standard Deviation
  2.22  ± 2.16     2.06  ± 2.03     2.14  ± 2.10  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Plan/Organize [15]
[units: units on a scale]
Mean ± Standard Deviation
  23.25  ± 4.02     23.31  ± 3.91     23.28  ± 3.96  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - SHIFT [16]
[units: units on a scale]
Mean ± Standard Deviation
  12.56  ± 2.82     12.36  ± 2.64     12.46  ± 2.73  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Self Monitor [17]
[units: units on a scale]
Mean ± Standard Deviation
  12.80  ± 3.01     12.25  ± 2.89     12.52  ± 2.96  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Task Monitor [18]
[units: units on a scale]
Mean ± Standard Deviation
  14.44  ± 2.36     14.68  ± 2.31     14.56  ± 2.33  
Behavior Rating Inventory of Executive Function-Adult Version Self Report - Working Memory [19]
[units: units on a scale]
Mean ± Standard Deviation
  19.87  ± 2.73     19.87  ± 2.69     19.87  ± 2.71  
Behavior Rating Inventory of Executive Function-Adult Version Self Report- Organization of Materials [20]
[units: units on a scale]
Mean ± Standard Deviation
  18.82  ± 4.07     19.00  ± 3.87     18.91  ± 3.97  
Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) [21]
[units: units on a scale]
Mean ± Standard Deviation
  4.79  ± 0.66     4.68  ± 0.64     4.74  ± 0.65  
Conners' ADHD Rating Scale Self Report (CAARS-S:SV) Total Score [22]
[units: units on a scale]
Mean ± Standard Deviation
  35.01  ± 8.97     35.69  ± 8.60     35.36  ± 8.78  
Conners' Adult ADHD Rating Scale - Investigator Rated:Screening Version Total Score [23]
[units: units on a scale]
Mean ± Standard Deviation
  39.15  ± 7.48     38.95  ± 7.72     39.05  ± 7.59  
Driving Behavior Survey Self-Report [24]
[units: units on a scale]
Mean ± Standard Deviation
  79.86  ± 12.89     78.95  ± 12.46     79.41  ± 12.67  
Driving Behavior Survey-Other Report [25]
[units: units on a scale]
Mean ± Standard Deviation
  70.90  ± 10.13     78.00  ± 11.24     74.77  ± 11.21  
Epworth Sleepiness Scale (ESS) [26]
[units: units on a scale]
Mean ± Standard Deviation
  9.82  ± 4.71     9.60  ± 4.74     9.71  ± 4.72  
Fagerstrom Test for Nicotine Dependence (FTND) [27]
[units: units on a scale]
Mean ± Standard Deviation
  2.08  ± 2.10     2.33  ± 2.22     2.20  ± 2.16  
Habits Timeline Followback (TLFB) Incidence for Use of Alcohol [28]
[units: number of alcoholic drinks per day]
Mean ± Standard Deviation
  0.98  ± 1.33     1.08  ± 1.44     1.03  ± 1.38  
Habits Timeline Followback (TLFB) Incidence for Use of Caffeine [29]
[units: number of caffeinated drinks per day]
Mean ± Standard Deviation
  1.78  ± 1.72     1.87  ± 3.19     1.82  ± 2.55  
Habits Timeline Followback (TLFB) Incidence for Use of Drugs [30]
[units: ratio]
Mean ± Standard Deviation
  0.13  ± 0.15     0.27  ± 0.37     0.18  ± 0.24  
Habits Timeline Followback (TLFB) Incidence for Use of Marijuana [31]
[units: number of joints smoked per day]
Mean ± Standard Deviation
  0.39  ± 0.59     0.28  ± 0.38     0.34  ± 0.50  
Habits Timeline Followback (TLFB) Incidence for Use of Nicotine [32]
[units: number of nicotine-products used per day]
Mean ± Standard Deviation
  6.91  ± 7.73     6.41  ± 7.44     6.65  ± 7.57  
Montgomery Asberg Depression Rating Scale (MADRS) [33]
[units: units on a scale]
Mean ± Standard Deviation
  6.68  ± 4.28     6.29  ± 4.01     6.48  ± 4.14  
Social Adaptation Self-Evaluation Scale (SASS) [34]
[units: units on a scale]
Mean ± Standard Deviation
  36.99  ± 6.17     37.28  ± 5.93     37.14  ± 6.04  
[1] 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.
[2] 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.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] 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.
[9] 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.
[10] 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.
[11] 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.
[12] 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.
[13] 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.
[14] 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.
[15] 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.
[16] 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.
[17] 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.
[18] 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.
[19] 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.
[20] 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.
[21] 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.
[22] 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.
[23] 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.
[24] 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.
[25] 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.
[26] 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.
[27] 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).
[28] 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.
[29] 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.
[30] 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.
[31] 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.
[32] 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.
[33] 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.
[34] 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.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: Baseline, Week 12 ]

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

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

4.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

5.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

6.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

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

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

9.  Secondary:   Endpoint Scores in Patient Global Impression - Improvement (PGI-I)   [ Time Frame: Baseline, 12 weeks ]

10.  Secondary:   Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: Baseline, 12 weeks ]

11.  Secondary:   Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)   [ Time Frame: Baseline, 12 weeks ]

12.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

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

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

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

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

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

18.  Secondary:   Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)   [ Time Frame: Baseline, 12 weeks ]

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

20.  Secondary:   Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report   [ Time Frame: Baseline, 12 weeks ]

21.  Secondary:   Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report   [ Time Frame: Baseline, 12 weeks ]

22.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

23.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

24.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

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

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

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

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

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

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

31.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

32.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

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

34.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

35.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

36.  Secondary:   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   [ Time Frame: Baseline, 12 weeks ]

37.  Secondary:   Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)   [ Time Frame: Baseline, 12 weeks ]

38.  Secondary:   Responders by Baseline Smoking Status   [ Time Frame: 12 weeks ]

39.  Secondary:   Strong Responders by Baseline Smoking Status   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00510276     History of Changes
Other Study ID Numbers: 10803, B4Z-US-LYDZ
Study First Received: July 30, 2007
Results First Received: January 27, 2010
Last Updated: April 7, 2010
Health Authority: United States: Food and Drug Administration