Attention-Deficit/Hyperactivity Disorder
Conditions
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).
Interventions
DRUGABT-089
Subjects will take up to two 40 mg tablets once daily for 8 weeks.
DRUGPlacebo
Subjects will take one or two placebos once daily for the duration of the study.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAARS: Inv Total Score | Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self | Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 |
| TASS, AAQoL, WPAI | Day -1, Day 28, Day 56 |
| BRIEF-A, FTND | Day-1, Day 56 |
| QSU-Brief, Number of Cigarettes smoked per day | Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 |
Countries
United States
Outcome results
None listed