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The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate | Drug | |||
| lithium | Drug | |||
| divalproex | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale | ||
| Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Cerritos | California | United States | |||
| Research Site |
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| San Diego |
| California |
| United States |
| Research Site | New Haven | Connecticut | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Eagle | Idaho | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | Boston | Massachusetts | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Moorestown | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | New York | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Chapel Hill | North Carolina | United States |
| Research Site | Research Triangle Park | North Carolina | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Media | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Columbia | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Wichita Falls | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D008094 | Lithium |
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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