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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-089 | Drug | Subjects will take up to two 40 mg tablets once daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CAARS: Inv Total Score | Screening, Day -1, Day 7, Day 14, Day 28, Day 42 and Day 56 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Earle Bain | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 7546 | Lafayette | California | 94549 | United States | ||
| Site Reference ID/Investigator# 7551 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22795204 | Derived | Bain EE, Apostol G, Sangal RB, Robieson WZ, McNeill DL, Abi-Saab WM, Saltarelli MD. A randomized pilot study of the efficacy and safety of ABT-089, a novel alpha4beta2 neuronal nicotinic receptor agonist, in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2012 Jun;73(6):783-9. doi: 10.4088/JCP.10m06719. |
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| Placebo | Drug | Subjects will take one or two placebos once daily for the duration of the study. |
|
| 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 |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Site Reference ID/Investigator# 7553 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 7545 | Overland Park | Kansas | 66212 | United States |
| Site Reference ID/Investigator# 7552 | Farmington Hills | Michigan | 48336 | United States |
| Site Reference ID/Investigator# 7548 | Troy | Michigan | 48085 | United States |
| Site Reference ID/Investigator# 7554 | Eugene | Oregon | 97401 | United States |
| Site Reference ID/Investigator# 7547 | Portland | Oregon | 97210 | United States |
| Site Reference ID/Investigator# 7555 | Memphis | Tennessee | 38119 | United States |
| Site Reference ID/Investigator# 7549 | Virginia Beach | Virginia | 23452 | United States |
| Site Reference ID/Investigator# 7550 | Bellevue | Washington | 98007 | United States |
| Site Reference ID/Investigator# 7631 | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C108326 | pozanicline |
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