Trial record 2 of 56 for:    Young and Strong

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
  Purpose

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

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

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


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Atomoxetine hydrochloride
Drug: Placebo
Phase 4

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
Official Title: A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    CAARS-Inv:SV is a 30-item scale containing 3 subscales: the Inattention subscale, the Hyperactivity-Impulsivity subscale, and the ADHD Index. The 18-item total ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales. Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently). The scale assesses symptom severity over the past week. The total score ranges from 0 to 54.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Endpoint Scores in Patient Global Impression - Improvement (PGI-I) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Responders by Baseline Smoking Status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Strong Responders by Baseline Smoking Status [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 445
Study Start Date: August 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atomoxetine Drug: Atomoxetine hydrochloride
20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
Other Names:
  • LY139603
  • Strattera
Placebo Comparator: Placebo Drug: Placebo
twice a day, by mouth for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least moderate severity
  • male or female 18 to 30 years of age
  • must be able to swallow capsules
  • must be able to communicate effectively in English
  • must not have cognitive impairment
  • be reliable to keep appointments for clinic visits and all related tests

Exclusion Criteria:

  • patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis
  • females who are pregnant or breastfeeding
  • patients with dementia or traumatic brain injury
  • patients with a history of severe allergy to atomoxetine
  • have untreated hypertension or thyroid problem
  • have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510276

  Show 29 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pathologic Processes
Atomoxetine
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014