A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00429091
Last Updated: 2010-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
243 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
placebo
Subjects will take BID for up to four weeks
2
ABT-894
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
3
atomoxetine
Subjects will take 40 mg BID or placebo for up to four weeks.
Interventions
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ABT-894
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
atomoxetine
Subjects will take 40 mg BID or placebo for up to four weeks.
placebo
Subjects will take BID for up to four weeks
Eligibility Criteria
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Inclusion Criteria
* Have voluntarily signed an informed form
* Are between 18 and 60 years of age
* Will use contraceptive methods during the study
* Women must not be pregnant or breast-feeding
* Must be in generally good health
* Are fluent in English
Exclusion Criteria
* They have a current diagnosis of major depressive episode, generalized anxiety disorder (GAD), or post-traumatic stress disorder (PTSD) or has a clinically significant sleep disorder requiring treatment
* They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
* They require ongoing treatment or expected treatment with Coumadin
* They failed to respond to two or more adequate trials of FDA-approved ADHD medication
* They have taken atomoxetine during the last 3 months
* They have violent, homicidal or suicidal ideation
* They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, or a central nervous system (CNS) disease, excluding ADHD
* They have a urine drug screen that is positive for alcohol or drugs of abuse
* They have a history of substance or alcohol disorder during the last 3 months
18 Years
60 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Earle Bain, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 5965
San Francisco, California, United States
Site Reference ID/Investigator# 5955
Wildomar, California, United States
Site Reference ID/Investigator# 5974
Orlando, Florida, United States
Site Reference ID/Investigator# 5956
West Palm Beach, Florida, United States
Site Reference ID/Investigator# 5973
Libertyville, Illinois, United States
Site Reference ID/Investigator# 5968
Overland Park, Kansas, United States
Site Reference ID/Investigator# 5952
Rockville, Maryland, United States
Site Reference ID/Investigator# 5962
Boston, Massachusetts, United States
Site Reference ID/Investigator# 5954
Okemos, Michigan, United States
Site Reference ID/Investigator# 5970
Troy, Michigan, United States
Site Reference ID/Investigator# 5960
Clementon, New Jersey, United States
Site Reference ID/Investigator# 5963
Charlotte, North Carolina, United States
Site Reference ID/Investigator# 5975
Eugene, Oregon, United States
Site Reference ID/Investigator# 5971
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 5957
Charleston, South Carolina, United States
Site Reference ID/Investigator# 5972
Austin, Texas, United States
Site Reference ID/Investigator# 5959
Bellaire, Texas, United States
Site Reference ID/Investigator# 5969
San Antonio, Texas, United States
Site Reference ID/Investigator# 5951
Salt Lake City, Utah, United States
Site Reference ID/Investigator# 5964
Burlington, Vermont, United States
Site Reference ID/Investigator# 5953
Virginia Beach, Virginia, United States
Site Reference ID/Investigator# 5958
Bellevue, Washington, United States
Countries
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Other Identifiers
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M06-818
Identifier Type: -
Identifier Source: org_study_id