A Dose-Ranging, Cross-over Study of the Safety and Efficacy of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Attention-Deficit/Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT00391729

Run by

Abbott

People needed

221

Starts

2006-10-01

Expected to finish

2007-06-01

Last updated by the study team

2011-10-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Lafayette, California, United States
• Study site — Oceanside, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Newton, Kansas, United States
• Study site — Farmington Hills, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Bridgewater, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Staten Island, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Lyndhurst, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Lake Jackson, Texas, United States
• Study site — Herndon, Virginia, United States
• Study site — Middleton, Wisconsin, United States

Full record on ClinicalTrials.gov

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