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This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in Part A. An interim analysis will be conducted to assess the efficacy and safety of the SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of SB-773812 will be added to the randomization for Part B.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-773812 | Drug | |||
| Olanzapine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| total score for each SB-773812 dose versus placebo at Week 6. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety of SB-773812 versus placebo and compared to olanzapine using PANNS scores -Measure the preliminary pharmacokinetic/pharmacodynamic relationships for SB-773812 -Assessment of movement disorders and cognitive functioning | 12 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 | Birmingham | Alabama | 35233 | United States | ||
| GSK Investigational Site |
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| Cerritos |
| California |
| 90703 |
| United States |
| GSK Investigational Site | Garden Grove | California | 92845 | United States |
| GSK Investigational Site | National City | California | 91950 | United States |
| GSK Investigational Site | San Diego | California | 92126 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06519 | 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 | Clementon | New Jersey | 08021 | United States |
| GSK Investigational Site | Kenilworth | New Jersey | 07033 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | Orangeburg | New York | 10962 | United States |
| GSK Investigational Site | Butner | North Carolina | 27509 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267 | United States |
| GSK Investigational Site | Bellaire | Texas | 77401 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Falls Church | Virginia | 22041 | United States |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Montignies-sur-Sambre | 6061 | Belgium |
| GSK Investigational Site | San José | Costa Rica |
| GSK Investigational Site | Brno | 625 00 | Czechia |
| GSK Investigational Site | Lnáře | Czechia |
| GSK Investigational Site | Prague | 181 00 | Czechia |
| GSK Investigational Site | Ahmedabad | 380010 | India |
| GSK Investigational Site | Bangalore | 560010 | India |
| GSK Investigational Site | Bangalore | 560029 | India |
| GSK Investigational Site | Bangalore | 560034 | India |
| GSK Investigational Site | Hyderabad | 500 034 | India |
| GSK Investigational Site | Lucknow | 226003 | India |
| GSK Investigational Site | Ludhiana | 141001 | India |
| GSK Investigational Site | Mangalore | 575001 | India |
| GSK Investigational Site | Pune | 411001 | India |
| GSK Investigational Site | Tirupati | 517507 | India |
| GSK Investigational Site | Lima | Lima Province | Peru |
| GSK Investigational Site | Leningraskaya Region | 188357 | Russia |
| GSK Investigational Site | Moscow | 107076 | Russia |
| GSK Investigational Site | Moscow | 115522 | Russia |
| GSK Investigational Site | Moscow | 119992 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603115 | Russia |
| GSK Investigational Site | Saint Petersburg | 190121 | Russia |
| GSK Investigational Site | Saint Petersburg | 192019 | Russia |
| GSK Investigational Site | Saint Petersburg | 193167 | Russia |
| GSK Investigational Site | Saint Petersburg | 197341 | Russia |
| GSK Investigational Site | Smolensk | 214 019 | Russia |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| 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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