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 children with Attention-Deficit/Hyperactivity Disorder or ADHD.
Interventions
DRUGABT-089
Subjects will take 0.5 and 1 and/or 5 and/or 10 mg ABT-089 tablets (actual dose based on weight) once daily for 8 weeks.
DRUGatomoxetine
Subjects will take 10, and/or 18 and/or 25 mg atomoxetine tablets once daily for 8 weeks.
DRUGplacebo
Subject will take a tablet once daily for 8 weeks
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 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 parent(s) * First grade or higher in a school setting 3 days/week * Subject is generally in good health based on medical history, physical examination, clinical lab tests, and ECG * Subject weighs at least 37 pounds (17 kg) * Female subjects of childbearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements * Subject and parents have been judged by the study doctor to be reliable to keep required appointments for clinic visits and all tests, including blood draws, and examinations
Exclusion criteria
* Subject is not functioning at an age-appropriate level intellectually * Subject has a current or past diagnosis of bipolar disorder, psychosis, autism, Asperger's syndrome, or pervasive developmental disorder * Current diagnosis of obsessive-compulsive disorder, eating disorder, anxiety disorder or depressive disorder requiring treatment of any kind * Subject has a history of significant allergic reaction to any drug * Subject requires ongoing treatment with any psychiatric medication * Subject has a serious medical condition, seizure disorder (except febrile seizures as an infant), or history of substance abuse or dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD-RS-IV (HV) - Administered by study doctor | Screening, Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Health Outcomes Measurements | Baseline to Final Evaluation of 8-week treatment period |
| Clinical Global Impression-ADHD-Severity Scale | Baseline to Final Evaluation of 8-week treatment period |
| Parent Rating Scales | Baseline to Final Evaluation of 8-week treatment period |
| Teacher Rating Scale | Baseline to Final Evaluation of 8-week treatment period |
Countries
United States
Outcome results
None listed