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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-089 | Drug | Subjects will take 2 mg QD, 5 mg QD, 15 mg QD, 40 mg QD, 40 mg BID for 4-6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-rated Connors' Adult ADHD Rating Scale(CAARS) total score | at the final evaluation of each 4-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| CAARS Inattentive and Hyperactive/Impulsive Sub scales Scores | at the final evaluation of each 4-week treatment period | |
| CAARS ADHD Index, CAARS:Self | at the final evaluation of each 4-week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gault, MD,PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mesa | Arizona | 85210 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21748252 | Derived | Apostol G, Abi-Saab W, Kratochvil CJ, Adler LA, Robieson WZ, Gault LM, Pritchett YL, Feifel D, Collins MA, Saltarelli MD. Efficacy and safety of the novel alpha(4)beta(2) neuronal nicotinic receptor partial agonist ABT-089 in adults with attention-deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled crossover study. Psychopharmacology (Berl). 2012 Feb;219(3):715-25. doi: 10.1007/s00213-011-2393-2. Epub 2011 Jul 12. |
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| Placebo |
| Drug |
Subjects will take placebo QD, BID for 4-6 weeks |
|
| CGI-ADHD-S, AISRS, TASS, FTND | at the final evaluation of each 4-week treatment period |
| QSU-Brief, CANTAB cognitive battery | at the final evaluation of each 4-week treatment period |
| Lafayette |
| California |
| 94549 |
| United States |
| Oceanside | California | 92056 | United States |
| San Diego | California | 92103 | United States |
| Denver | Colorado | 80212 | United States |
| Jacksonville | Florida | 32216 | United States |
| Maitland | Florida | 32751 | United States |
| Miami | Florida | 33173 | United States |
| Tampa | Florida | 33606 | United States |
| Newton | Kansas | 67114 | United States |
| Farmington Hills | Michigan | 48336 | United States |
| Omaha | Nebraska | 68198 | United States |
| Bridgewater | New Jersey | 10312 | United States |
| New York | New York | 10010 | United States |
| Staten Island | New York | 10312 | United States |
| Chapel Hill | North Carolina | 27514 | United States |
| Lyndhurst | Ohio | 44124 | United States |
| Portland | Oregon | 97210 | United States |
| Charleston | South Carolina | 29405 | United States |
| Memphis | Tennessee | 38119 | United States |
| Lake Jackson | Texas | 77566 | United States |
| Herndon | Virginia | 20170 | United States |
| Middleton | Wisconsin | 53562 | 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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