Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT ID: NCT00640185
Last Updated: 2013-01-18
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
160 participants
INTERVENTIONAL
2008-03-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Placebo
Subjects will take one or two placebos once daily for the duration of the study.
2
ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Placebo
Subjects will take one or two placebos once daily for the duration of the study.
3
ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Placebo
Subjects will take one or two placebos once daily for the duration of the study.
Interventions
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ABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
Placebo
Subjects will take one or two placebos once daily for the duration of the study.
Eligibility Criteria
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Inclusion Criteria
* Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject.
* Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG.
* Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements.
* Male subjects must agree to comply with applicable contraceptive requirements.
* Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations.
Exclusion Criteria
* Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind.
* Subject has a history of, or ongoing, serious medical problem.
* Subject has a history of significant allergic reaction to any drug.
* Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD.
* Subject requires ongoing treatment with any psychiatric medication.
18 Years
60 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Earle Bain
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 7546
Lafayette, California, United States
Site Reference ID/Investigator# 7551
Jacksonville, Florida, United States
Site Reference ID/Investigator# 7553
Orlando, Florida, United States
Site Reference ID/Investigator# 7545
Overland Park, Kansas, United States
Site Reference ID/Investigator# 7552
Farmington Hills, Michigan, United States
Site Reference ID/Investigator# 7548
Troy, Michigan, United States
Site Reference ID/Investigator# 7554
Eugene, Oregon, United States
Site Reference ID/Investigator# 7547
Portland, Oregon, United States
Site Reference ID/Investigator# 7555
Memphis, Tennessee, United States
Site Reference ID/Investigator# 7549
Virginia Beach, Virginia, United States
Site Reference ID/Investigator# 7550
Bellevue, Washington, United States
Site Reference ID/Investigator# 7631
Seattle, Washington, United States
Countries
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References
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Bain EE, Apostol G, Sangal RB, Robieson WZ, McNeill DL, Abi-Saab WM, Saltarelli MD. A randomized pilot study of the efficacy and safety of ABT-089, a novel alpha4beta2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jun;73(6):783-9. doi: 10.4088/JCP.10m06719.
Other Identifiers
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M10-346
Identifier Type: -
Identifier Source: org_study_id
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