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Sponsor Decision- Financial Considerations
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The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Zonisamide SR 360 mg and olanzapine 10-20 mg daily |
|
| 2 | Placebo Comparator | Placebo and olanzapine 10-20 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zonisamide SR plus olanzapine | Drug | zonisamide SR 90 mg given twice daily and olanzapine 10 mg to 20 mg daily for 10 weeks (maintenance period) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in total body weight | Baseline to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Breier, MD | Larue D. Carter Hospital | Principal Investigator |
| Mohammed Alam, MD | American Medical Research | Principal Investigator |
| Gerald Maguire, MD | UCI Medical Center | Principal Investigator |
| Zinoviy Benzar, MD | Brooklyn Medical Institute | Principal Investigator |
| Mohammed Bari, MD | Synergy Research | Principal Investigator |
| Tran Johnson, MD | CNRI | Principal Investigator |
| Eduard Gfeller, MD | Florida Clinical Research Center, Maitland Florida | Principal Investigator |
| Andrew Cutler, MD | Florida Clinical Research Center, Bradenton Florida | Principal Investigator |
| Robert Riesenberg, MD | Atlanta Center for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Research | National City | California | 91950 | United States | ||
| UCI Medical Center |
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| Placebo plus olanzapine | Drug | Placebo given twice daily and olanzapine 10-20 mg for 10 weeks (maintenance period) |
|
|
| Orange |
| California |
| 92868 |
| United States |
| CNRI San Diego | San Diego | California | 92126 | United States |
| Florida Clincal Research Center | Bradenton | Florida | 34208 | United States |
| Florida Clinical Research Center | Maitland | Florida | 34208 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| American Medical Research | Oak Brook | Illinois | 60523 | United States |
| Larue D. Carter Hospital | Indianapolis | Indiana | 46222 | United States |
| Brooklyn Medical Institute | Brooklyn | New York | 11223 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| 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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