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This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.
This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bifeprunox, olanzapine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline on body weight at the final evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in triglyceride level; Change from baseline in waist circumference; and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72201 | United States | |||
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| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Anaheim | California | 92802 | United States |
| Anaheim | California | 92804 | United States |
| Anaheim | California | 92805 | United States |
| Boynton Beach | California | 33426 | United States |
| Costa Mesa | California | 92363 | United States |
| Costa Mesa | California | 92627 | United States |
| Escondido | California | 92025 | United States |
| Garden Grove | California | 92845 | United States |
| Glendale | California | 91206 | United States |
| Huntington Beach | California | 92648 | United States |
| La Mesa | California | 91942 | United States |
| National City | California | 91950 | United States |
| Oceanside | California | 92056 | United States |
| Paramount | California | 90723 | United States |
| Rosemead | California | 91770 | United States |
| San Diego | California | 92108 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92126 | United States |
| Santa Ana | California | 92705 | United States |
| New Britain | Connecticut | 06050 | United States |
| New London | Connecticut | 06320 | United States |
| DeLand | Florida | 32720 | United States |
| Fort Lauderdale | Florida | 33319 | United States |
| Jacksonville | Florida | 32256 | United States |
| North Miami | Florida | 33161 | United States |
| St. Petersburg | Florida | 33711 | United States |
| Atlanta | Georgia | 30308 | United States |
| Augusta | Georgia | 30912 | United States |
| Marietta | Georgia | 30060 | United States |
| Coevr d'Alene | Idaho | 83814 | United States |
| Chicago | Illinois | 60631 | United States |
| Hoffman Estates | Illinois | 60194 | United States |
| Joliet | Illinois | 60077 | United States |
| Naperville | Illinois | 60540 | United States |
| Lake Charles | Louisiana | 70601 | United States |
| Gaithersburg | Maryland | 20877 | United States |
| Worcester | Massachusetts | 01605 | United States |
| Flowood | Mississippi | 39232 | United States |
| St Louis | Missouri | 63110 | United States |
| St Louis | Missouri | 63118 | United States |
| St Louis | Missouri | 63128 | United States |
| North Platte | Nebraska | 69101 | United States |
| Cherry Hill | New Jersey | 08002 | United States |
| Clementon | New Jersey | 08021 | United States |
| New York | New York | 10035 | United States |
| Rochester | New York | 14624 | United States |
| Staten Island | New York | 10312 | United States |
| Butner | North Carolina | 27509 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Durham | North Carolina | 27707 | United States |
| Morehead City | North Carolina | 28557 | United States |
| Fargo | North Dakota | 58102 | United States |
| Cleveland | Ohio | 44109 | United States |
| Oklahoma City | Oklahoma | 73118 | United States |
| Oklahoma City | Oklahoma | 73139 | United States |
| Norristown | Pennsylvania | 19401 | United States |
| Philadelphia | Pennsylvania | 19149 | United States |
| Pittsburgh | Pennsylvania | 15108 | United States |
| Cordova | Tennessee | 38018 | United States |
| Memphis | Tennessee | 38105 | United States |
| Murfressboro | Tennessee | 37129 | United States |
| Nashville | Tennessee | 37212 | United States |
| Austin | Texas | 78756 | United States |
| DeSoto | Texas | 75115 | United States |
| Irving | Texas | 75062 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C509981 | bifeprunox |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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