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The purpose of this study is to assess the 14-day and 12-week safety and efficacy of Depakote ER used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium Extended-Release Tablets | Drug | |||
| Olanzapine | Drug | |||
| Risperidone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The psychiatric rating scale battery will include the PANSS, the CGI Scale, and the CDSS. The NOSIE, Overall Treatment Evaluation, Burden Questionnaire, and Quality of Life Scale. |
| Measure | Description | Time Frame |
|---|---|---|
| The movement rating scale battery will include the Simpson-Angus Scale (SAS), the Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS). |
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KEY INCLUSION CRITERIA:
KEY EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Information 800-633-9110 | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Tuscaloosa |
| Alabama |
| United States |
| Anaheim | California | United States |
| Cerritos | California | United States |
| Chula Vista | California | United States |
| Garden Grove | California | United States |
| Glendale | California | United States |
| Los Angeles | California | United States |
| San Diego | California | United States |
| Denver | Colorado | United States |
| Gainsville | Florida | United States |
| Melbourne | Florida | United States |
| North Miami | Florida | United States |
| Winter Park | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Hoffman Estates | Illinois | United States |
| Indianapolis | Indiana | United States |
| South Bend | Indiana | United States |
| Shreveport | Louisiana | United States |
| Rockville | Maryland | United States |
| Jackson | Mississippi | United States |
| Clementon | New Jersey | United States |
| Kenilworth | New Jersey | United States |
| Holliswood | New York | United States |
| New York | New York | United States |
| Butner | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Austin | Texas | United States |
| Irving | Texas | United States |
| San Antonio | Texas | United States |
| Falls Church | Virginia | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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