A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Phase 2
Completed
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT00391729
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Placebo - 2 ABT-089 -
- Primary Outcome Measures
Name Time Method Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score at the final evaluation of each 4-week treatment period
- Secondary Outcome Measures
Name Time Method 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