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

Abbott

Status and phase

Completed

Phase 2

Conditions

Attention-Deficit/Hyperactivity Disorder

Treatments

Drug: Placebo

Drug: ABT-089

Study type

Interventional

Funder types

Industry

Identifiers

NCT00391729

M06-855

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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