Safety, Tolerability and Efficacy Study of ABT-089 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Official Title
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A Pilot, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of the Safety, Tolerability and Efficacy of 40 mg QD and 80 mg QD ABT-089 in Adults With Attention Deficit-Hyperactivity Disorder (ADHD)

Conditions
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Attention-Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Drug: ABT-089
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have voluntarily signed an informed consent form. Meet diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) based on detailed evaluation and interview with subject. Subject is generally in good health based on medical history, physical examination, clinical lab tests and ECG. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening and baseline and agree to comply with applicable contraceptive requirements. Male subjects must agree to comply with applicable contraceptive requirements. Subject is able to keep required appointments for clinic visits and all tests, including blood draws and examinations. Exclusion Criteria: Subject has a current or past diagnosis of schizoaffective disorder, schizophrenia, obsessive-compulsive disorder, drug-induced psychosis, bipolar disorder, psychotic disorder. Current diagnosis of major depressive disorder, generalized anxiety disorder, PTSD or has a sleep disorder requiring treatment of any kind. Subject has a history of, or ongoing, serious medical problem. Subject has a history of significant allergic reaction to any drug. Subject is planning to begin any type of behavioral or psychotherapy for treatment of ADHD. Subject requires ongoing treatment with any psychiatric medication.

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: ABT-089<br>* Subjects will take up to two 40 mg tablets once daily for 8 weeks.<br>Drug: Placebo<br>* Subjects will take one or two placebos once daily for the duration of the study.<br>|
| Experimental: 2<br> | Drug: ABT-089<br>* Subjects will take up to two 40 mg tablets once daily for 8 weeks.<br>Drug: Placebo<br>* Subjects will take one or two placebos once daily for the duration of the study.<br>|
| Experimental: 3<br> | Drug: ABT-089<br>* Subjects will take up to two 40 mg tablets once daily for 8 weeks.<br>Drug: Placebo<br>* Subjects will take one or two placebos once daily for the duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS: Inv Total Score |  | Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS Inattentive and Hyperactive/Impulsivity Sub-scale scores, CAARS ADHD Index, CGI-ADHD-S, AISRS, CAARS:Self |  | Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 | 
| TASS, AAQoL, WPAI |  | Day -1, Day 28, Day 56 | 
| BRIEF-A, FTND |  | Day-1, Day 56 | 
| QSU-Brief, Number of Cigarettes smoked per day |  | Day -1, Day 7, Day 14, Day 28, Day 42, Day 56 |