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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 children with Attention Deficit Hyperactivity Disorder (ADHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-089 | Drug | Subjects will take 10 mg capsules and/or 40 mg tablets (actual dose based on weight) once daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ADHD-RS-IV (HV) | Screening, Day -1, Day 7, Day 14, Day 28, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| CSHQ | Day-1, Day 28, Day 42 | |
| CGI-P | Day -1, Day 21, Day 42 | |
| BRIEF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Gault | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 7536 | Little Rock | Arkansas | 72205 | United States | ||
| Site Reference ID/Investigator# 7954 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21156272 | Derived | Wilens TE, Gault LM, Childress A, Kratochvil CJ, Bensman L, Hall CM, Olson E, Robieson WZ, Garimella TS, Abi-Saab WM, Apostol G, Saltarelli MD. Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry. 2011 Jan;50(1):73-84.e1. doi: 10.1016/j.jaac.2010.10.001. Epub 2010 Nov 25. |
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| placebo | Drug | Subjects will take placebo capsules and/or tablets (number of capsules or tablets will be based upon weight) once daily for duration of the study. |
|
| Day -1, Day 28, Day 42 |
| CGI-ADHD-S | Screening, Day -1, Day 7, Day 14, Day 28 and Day 42 |
| Bradenton |
| Florida |
| 34208 |
| United States |
| Site Reference ID/Investigator# 7543 | Jacksonville | Florida | 32216 | United States |
| Site Reference ID/Investigator# 7542 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 7537 | Libertyville | Illinois | 60048 | United States |
| Site Reference ID/Investigator# 7561 | Overland Park | Kansas | 66212 | United States |
| Site Reference ID/Investigator# 7560 | Troy | Michigan | 48085 | United States |
| Site Reference ID/Investigator# 7559 | Omaha | Nebraska | 68198 | United States |
| Site Reference ID/Investigator# 7541 | Las Vegas | Nevada | 89128 | United States |
| Site Reference ID/Investigator# 7564 | Oklahoma City | Oklahoma | 73103 | United States |
| Site Reference ID/Investigator# 7538 | Portland | Oregon | 97210 | United States |
| Site Reference ID/Investigator# 7540 | Memphis | Tennessee | 38119 | United States |
| Site Reference ID/Investigator# 7544 | Bellevue | Washington | 98007 | 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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