A Dose-Ranging Study of the Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Abbott

Status and phase: Completed; Phase 2

Conditions: Attention-Deficit/Hyperactivity Disorder; ADHD

Treatments: Drug: ABT-894; Drug: atomoxetine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00429091

M06-818

Details and patient eligibility

About

A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)

Enrollment: 243 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 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 has a clinically significant sleep disorder requiring treatment
• They require ongoing treatment or expected treatment with any psychotropic medication, including anxiolytics, antipsychotics, anticonvulsants, antidepressants, mood stabilizers, nicotine replacement therapies or varenicline
• They require ongoing treatment or expected treatment with Coumadin
• They failed to respond to two or more adequate trials of FDA-approved ADHD medication
• They have taken atomoxetine during the last 3 months
• They have violent, homicidal or suicidal ideation
• They have a significant history of medical diagnoses, seizure disorder, Tourette's syndrome, traumatic brain injury, 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 during the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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243 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: placebo

2

Experimental group

Treatment:

Drug: ABT-894

3

Active Comparator group

Treatment:

Drug: atomoxetine