- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510276
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Hato Rey, Puerto Rico, 00918
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico, 00907
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Los Angeles, California, United States, 90024
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rolling Hills Est., California, United States, 90274
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Spring Valley, California, United States, 91978
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Wildomar, California, United States, 92595
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Florida
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Gainesville, Florida, United States, 32607
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jacksonville, Florida, United States, 32216
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South Miami, Florida, United States, 33143
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St. Petersburg, Florida, United States, 33709
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Eagle, Idaho, United States, 83616
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Topeka, Kansas, United States, 66606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Lexington, Kentucky, United States, 40509
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Michigan
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Farmington Hills, Michigan, United States, 48336
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nebraska
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Omaha, Nebraska, United States, 68198
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas, Nevada, United States, 89128
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Jersey
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Piscataway, New Jersey, United States, 08854
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New York
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New York, New York, United States, 10010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Charlotte, North Carolina, United States, 28211
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Beachwood, Ohio, United States, 44122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cincinnati, Ohio, United States, 45267
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Charleston, South Carolina, United States, 29405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vermont
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Burlington, Vermont, United States, 05401
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Woodstock, Vermont, United States, 05091
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Midlothian, Virginia, United States, 23112
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Seattle, Washington, United States, 98104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Spokane, Washington, United States, 99202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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twice a day, by mouth for 12 weeks
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Experimental: Atomoxetine
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20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Endpoint Scores in Patient Global Impression - Improvement (PGI-I)
Time Frame: Baseline, 12 weeks
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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).
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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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
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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. |
Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)
Time Frame: Baseline, 12 weeks
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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).
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Baseline, 12 weeks
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Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report
Time Frame: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
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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.
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Baseline, 12 weeks
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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
|
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.
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Baseline, 12 weeks
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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
|
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.
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Baseline, 12 weeks
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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
|
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.
|
Baseline, 12 weeks
|
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
|
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.
|
Baseline, 12 weeks
|
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
|
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.
|
Baseline, 12 weeks
|
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
|
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.
|
Baseline, 12 weeks
|
Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, 12 weeks
|
Used to determine the level of daytime sleepiness.
The ESS is a self-rated questionnaire with 8 items that describe normative daily situations known to vary in their soporific qualities.
Subjects rate the likelihood of dozing off or falling asleep in each of these situations.
Each item is rated on a 4-point scale from 0 (would never doze) to 3 (high chance of dozing).
The item scores are summed to produce a total score (range of 0-24).
Score >10 (95th percentile) are considered to be suggestive of significant daytime sleepiness.
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Baseline, 12 weeks
|
Responders by Baseline Smoking Status
Time Frame: 12 weeks
|
Baseline smoking status was recorded and associations to response to treatment were determined.
Response was defined as 25% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score.
The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales.
Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently).
The scale assesses symptom severity over the past week.
The total score ranges from 0 to 54.
|
12 weeks
|
Strong Responders by Baseline Smoking Status
Time Frame: 12 weeks
|
Baseline smoking status was recorded and associations to response to treatment were determined.
Strong response was defined as 40% or greater decrease in ADHD symptoms as measured by the CAARS-Inv:SV total ADHD symptom score.
The 18-item total CAARS-Inv:SV ADHD symptom score is the sum of the Inattention and Hyperactivity-Impulsivity subscales.
Each item is scored on a 0 to 3 scale (0=not at all, never; 1=just a little, once in a while; 2=pretty much, often; 3=very much, very frequently).
The scale assesses symptom severity over the past week.
The total score ranges from 0 to 54.
|
12 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
- Adler LA, Clemow DB, Williams DW, Durell TM. Atomoxetine effects on executive function as measured by the BRIEF--a in young adults with ADHD: a randomized, double-blind, placebo-controlled study. PLoS One. 2014 Aug 22;9(8):e104175. doi: 10.1371/journal.pone.0104175. eCollection 2014.
- Durell TM, Adler LA, Williams DW, Deldar A, McGough JJ, Glaser PE, Rubin RL, Pigott TA, Sarkis EH, Fox BK. Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial. J Clin Psychopharmacol. 2013 Feb;33(1):45-54. doi: 10.1097/JCP.0b013e31827d8a23. Erratum In: J Clin Psychopharmacol. 2014 Aug;34(4):542-3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 10803
- B4Z-US-LYDZ (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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