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The purpose of this study is to test the safety and effectiveness of talnetant vs. risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic schizophrenia patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talnetant | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arkansas | 72201 | United States | ||
| GSK Investigational Site |
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| Anaheim |
| California |
| 92805 |
| United States |
| GSK Investigational Site | Cerritos | California | 90703 | United States |
| GSK Investigational Site | Garden Grove | California | 92845 | United States |
| GSK Investigational Site | Glendale | California | 91206 | United States |
| GSK Investigational Site | National City | California | 91950 | United States |
| GSK Investigational Site | Oceanside | California | 92056 | United States |
| GSK Investigational Site | Pico Rivera | California | 90660 | United States |
| GSK Investigational Site | Rosemead | California | 91770 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| GSK Investigational Site | North Miami | Florida | 33161 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | St Louis | Missouri | 63118 | United States |
| GSK Investigational Site | Clementon | New Jersey | 08021 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19131 | United States |
| GSK Investigational Site | Austin | Texas | 78756 | United States |
| GSK Investigational Site | Irving | Texas | 75062 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | 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 |
|---|---|
| C106716 | SB 223412 |
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