Status:
COMPLETED
Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Eligibility Criteria
Inclusion
- Have voluntarily signed an informed consent form.
- 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
- Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder.
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00640185
Start Date
March 1 2008
End Date
August 1 2008
Last Update
January 18 2013
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 7546
Lafayette, California, United States, 94549
2
Site Reference ID/Investigator# 7551
Jacksonville, Florida, United States, 32216
3
Site Reference ID/Investigator# 7553
Orlando, Florida, United States, 32806
4
Site Reference ID/Investigator# 7545
Overland Park, Kansas, United States, 66212