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

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

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose-Ranging Study of the Safety and Efficacy of ABT-894 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Conditions
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Attention-Deficit/Hyperactivity Disorder, ADHD

Intervention / Treatment
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* Drug: ABT-894
* Drug: atomoxetine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* Subjects will take BID for up to four weeks<br>|
| Experimental: 2<br> | Drug: ABT-894<br>* Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks.<br>|
| Active Comparator: 3<br> | Drug: atomoxetine<br>* Subjects will take 40 mg BID or placebo for up to four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales) |  | Final Evaluation of each 4-week Treatment Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS Inattentive and Hyperactive/Impulsive Sub-scales Scores |  | Final Evaluation of each 4-week Treatment Period | 
| CAARS ADHD Index |  | Final Evaluation of each 4-week Treatment Period | 
| CGI-ADHD-S |  | Final Evaluation of each 4-week Treatment Period | 
| AISRS |  | Final Evaluation of each 4-week Treatment Period | 
| CAARS:Self |  | Final Evaluation of each 4-week Treatment Period | 
| TASS |  | Final Evaluation of each 4-week Treatment Period | 
| FTND |  | Final Evaluation of each 4-week Treatment Period | 
| QSU-Brief |  | Final Evaluation of each 4-week Treatment Period | 
| CANTAB cognitive battery |  | Final Evaluation of each 4-week Treatment Period |