Status:
COMPLETED
A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Abbott
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
Eligibility Criteria
Inclusion
- Meet criteria for attention deficit hyperactivity disorder
- Have voluntarily signed an informed consent 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 have a clinically significant sleep disorder requiring treatment
- They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers
- They failed to respond to two or more adequate trials of FDA-approved ADHD medication
- They have violent, homicidal or suicidal ideation
- They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome 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 (abuse/dependence) during the last 3 months
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00391729
Start Date
October 1 2006
End Date
June 1 2007
Last Update
October 18 2011
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Mesa, Arizona, United States, 85210
2
Lafayette, California, United States, 94549
3
Oceanside, California, United States, 92056
4
San Diego, California, United States, 92103