Attention-Deficit/Hyperactivity Disorder
Conditions
Keywords
ADHD
Brief summary
The objective of this study is to compare the safety and efficacy of five doses of ABT-089 (2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD and 40 mg BID) to placebo in adults with ADHD.
Interventions
DRUGABT-089
Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks
DRUGPlacebo
Subjects will take placebo QD, BID for 4-6 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 consent 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 have a clinically significant sleep disorder requiring treatment * They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants or mood stabilizers * They failed to respond to two or more adequate trials of FDA-approved ADHD medication * They have violent, homicidal or suicidal ideation * They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome 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 (abuse/dependence) during the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score | at the final evaluation of each 4-week treatment period |
Secondary
| Measure | Time frame |
|---|---|
| CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores | at the final evaluation of each 4-week treatment period |
| CAARS ADHD Index, CAARS:Self | at the final evaluation of each 4-week treatment period |
| CGI-ADHD-S, AISRS, TASS, FTND | at the final evaluation of each 4-week treatment period |
| QSU-Brief, CANTAB cognitive battery | at the final evaluation of each 4-week treatment period |
Countries
United States
Outcome results
None listed