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A Dose-Ranging Study of the Efficacy of ABT-894 in Adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-894 | Drug | Subjects will take 1 mg QD, 2 mg QD, 4 mg QD, 4 mg BID for up to four weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| CAARS:Inv Total Score (Sum of Inattentive and Hyperactive/Impulsive Sub-scales) | Final Evaluation of each 4-week Treatment Period |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Earle Bain, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 5965 | San Francisco | California | 94143-0984 | United States | ||
| Site Reference ID/Investigator# 5955 |
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| atomoxetine |
| Drug |
Subjects will take 40 mg BID or placebo for up to four weeks. |
|
| placebo | Drug | Subjects will take BID for up to four weeks |
|
| 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 |
| Wildomar |
| California |
| 92595 |
| United States |
| Site Reference ID/Investigator# 5974 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 5956 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 5973 | Libertyville | Illinois | 60048 | United States |
| Site Reference ID/Investigator# 5968 | Overland Park | Kansas | 66212 | United States |
| Site Reference ID/Investigator# 5952 | Rockville | Maryland | 20852 | United States |
| Site Reference ID/Investigator# 5962 | Boston | Massachusetts | 02114 | United States |
| Site Reference ID/Investigator# 5954 | Okemos | Michigan | 48864 | United States |
| Site Reference ID/Investigator# 5970 | Troy | Michigan | 48085 | United States |
| Site Reference ID/Investigator# 5960 | Clementon | New Jersey | 08021 | United States |
| Site Reference ID/Investigator# 5963 | Charlotte | North Carolina | 28211 | United States |
| Site Reference ID/Investigator# 5975 | Eugene | Oregon | 97401 | United States |
| Site Reference ID/Investigator# 5971 | Philadelphia | Pennsylvania | 19149 | United States |
| Site Reference ID/Investigator# 5957 | Charleston | South Carolina | 29407 | United States |
| Site Reference ID/Investigator# 5972 | Austin | Texas | 78756 | United States |
| Site Reference ID/Investigator# 5959 | Bellaire | Texas | 77401 | United States |
| Site Reference ID/Investigator# 5969 | San Antonio | Texas | 78258 | United States |
| Site Reference ID/Investigator# 5951 | Salt Lake City | Utah | 84107 | United States |
| Site Reference ID/Investigator# 5964 | Burlington | Vermont | 05401 | United States |
| Site Reference ID/Investigator# 5953 | Virginia Beach | Virginia | 23452 | United States |
| Site Reference ID/Investigator# 5958 | 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 |
|---|---|
| C000593913 | 3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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