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| Name | Class |
|---|---|
| Solvay Pharmaceuticals | INDUSTRY |
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifeprunox | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary measurement scales will be used: | ||
| Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 | ||
| Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
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| Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 |
| Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8 |
| Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| National City | California | 91950 | United States |
| Stanford | California | 94305 | United States |
| Farmington Hills | Connecticut | 06030 | United States |
| Bradenton | Florida | 34208 | United States |
| Jacksonville | Florida | 32216 | United States |
| Orlando | Florida | 32806 | United States |
| West Palm Beach | Florida | 33407 | United States |
| Smyrna | Georgia | 30080 | United States |
| Honolulu | Hawaii | 96826 | United States |
| Terre Haute | Indiana | 47802 | United States |
| Florence | Kentucky | 41042 | United States |
| New Orleans | Louisiana | 70115 | United States |
| Rockville | Maryland | 20852 | United States |
| Boston | Massachusetts | 02114 | United States |
| Farmington Hills | Michigan | 48336 | United States |
| Saint Charles | Missouri | 63301 | United States |
| Clementon | New Jersey | 08021 | United States |
| Moorestown | New Jersey | 08057 | United States |
| Lawrence | New York | 11559 | United States |
| New York | New York | 10021 | United States |
| New York | New York | 10024 | United States |
| Staten Island | New York | 10305 | United States |
| The Bronx | New York | 10467 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Dayton | Ohio | 45408 | United States |
| Lyndhurst | Ohio | 44124 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Tulsa | Oklahoma | 74135 | United States |
| Portland | Oregon | 97210 | United States |
| Philadelphia | Pennsylvania | 19149 | United States |
| Charleston | South Carolina | 29407 | United States |
| Austin | Texas | 78756 | United States |
| Dallas | Texas | 75390 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Bellevue | Washington | 98004 | United States |
| Seattle | Washington | 98104 | United States |
| Brown Deer | Wisconsin | 53223 | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C509981 | bifeprunox |
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