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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott

Criteria

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