Attention-Deficit/Hyperactivity Disorder
Conditions
Keywords
Attention-Deficit/Hyperactivity Disorder
Brief summary
The objective of this study is to evaluate the long-term effects and tolerability of ABT-089 in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
Interventions
DRUGABT-089
Subjects will take up to 80 mg daily for 24 months
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* The subject was randomized into Study M10-346 and completed the study. * Female subjects of childbearing 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. * The subject is judged to be in generally good health.
Exclusion criteria
* The subject has taken any ADHD medication between the last dose of study drug in Study M10-346 and the first dose of study drug in the current study. * The subject anticipates a move outside the geographic area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAARS:Inv | Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
| CGI-ADHD-S | Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
Secondary
| Measure | Time frame |
|---|---|
| AAQOL | Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 |
| CAARS:Self | Day -1, Day 14, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
| FTND | Day -1, Month 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 |
| WPAI | Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 |
| BRIEF-A | Day -1, Month 3, 6, 9, 12, 15, 18, 21, 24 |
Countries
United States
Outcome results
None listed