Status:
COMPLETED
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Abbott
Conditions:
Attention-Deficit/Hyperactivity Disorder
ADHD
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
Eligibility Criteria
Inclusion
- Meet criteria for attention-deficit/hyperactivity disorder
- 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
- They have a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder or mental retardation
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT00429091
Start Date
January 1 2007
Last Update
November 2 2010
Active Locations (22)
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1
Site Reference ID/Investigator# 5965
San Francisco, California, United States, 94143-0984
2
Site Reference ID/Investigator# 5955
Wildomar, California, United States, 92595
3
Site Reference ID/Investigator# 5974
Orlando, Florida, United States, 32806
4
Site Reference ID/Investigator# 5956
West Palm Beach, Florida, United States, 33407