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This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| talnetant | Experimental | 200mg, 400mg, 600mg) twice a day |
|
| placebo | Placebo Comparator | placebo |
|
| risperidone | Active Comparator | 3mg twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talnetant | Drug | talnetant |
| |
| placebo |
| 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. | 6 weeks |
| 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). | 6 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | 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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| Other |
Placebo Comparator |
|
| risperidone | Other | Active Comparator |
|
| 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 | San Diego | California | 92126 | 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 | Oak Brook | Illinois | 60523 | 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 |
| D002389 | Catatonia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C106716 | SB 223412 |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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