Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
NCT ID: NCT00510276
Last Updated: 2010-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
445 participants
INTERVENTIONAL
2007-08-31
2009-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atomoxetine
Atomoxetine hydrochloride
20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
Placebo
Placebo
twice a day, by mouth for 12 weeks
Interventions
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Atomoxetine hydrochloride
20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
Placebo
twice a day, by mouth for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
30 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States
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Rolling Hills Est., California, United States
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Spring Valley, California, United States
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Wildomar, California, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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Eagle, Idaho, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Belmont, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Piscataway, New Jersey, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Charleston, South Carolina, United States
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Burlington, Vermont, United States
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Woodstock, Vermont, United States
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Midlothian, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Hato Rey, , Puerto Rico
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San Juan, , Puerto Rico
Countries
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References
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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.
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.
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.
Other Identifiers
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B4Z-US-LYDZ
Identifier Type: OTHER
Identifier Source: secondary_id
10803
Identifier Type: -
Identifier Source: org_study_id
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