ADHD, Attention-Deficit/Hyperactivity Disorder
Conditions
Brief summary
A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions
DRUGABT-894
Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.
DRUGatomoxetine
Subjects will take 40 mg BID or placebo for up to four weeks.
DRUGplacebo
Subjects will take BID for up to four weeks
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Meet criteria for attention-deficit/hyperactivity disorder * Have voluntarily signed an informed 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 criteria
* 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 has a clinically significant sleep disorder requiring treatment * They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline * They require ongoing treatment or expected treatment with Coumadin * They failed to respond to two or more adequate trials of FDA-approved ADHD medication * They have taken atomoxetine during the last 3 months * They have violent, homicidal or suicidal ideation * They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, 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 during the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales) | Final Evaluation of each 4-week Treatment Period |
Secondary
| Measure | Time frame |
|---|---|
| CAARS ADHD Index | Final Evaluation of each 4-week Treatment Period |
| CGI-ADHD-S | Final Evaluation of each 4-week Treatment Period |
| AISRS | Final Evaluation of each 4-week Treatment Period |
| CAARS:Self | Final Evaluation of each 4-week Treatment Period |
| CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores | Final Evaluation of each 4-week Treatment Period |
| FTND | Final Evaluation of each 4-week Treatment Period |
| QSU-Brief | Final Evaluation of each 4-week Treatment Period |
| CANTAB cognitive battery | Final Evaluation of each 4-week Treatment Period |
| TASS | Final Evaluation of each 4-week Treatment Period |
Countries
United States
Outcome results
None listed