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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004972-11 |
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
| Wyeth is now a wholly owned subsidiary of Pfizer | INDUSTRY |
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The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other |
| |
| B | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful switch defined as those who complete the 4 weeks core study with no worsening of 2 successive post baseline assessments on the CGIS, exacerbation of EPS, or cardiovascular risk factors (body weight and fasting triglycerides) from baseline. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 4 weeks | |
| Adverse events | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 148 | Birmingham | Alabama | United States | |||
| Site 194 |
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| Olanzapine | Drug | Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox |
|
| Risperidone | Drug | Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox |
|
| Quetiapine | Drug | Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox |
|
| Ziprasidone | Drug | Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox |
|
| Aripiprazole | Drug | Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days |
|
| Olanzapine | Drug | Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days |
|
| Risperidone | Drug | Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days |
|
| Quetiapine | Drug | Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days |
|
| Ziprasidone | Drug | Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days |
|
| Little Rock |
| Arkansas |
| United States |
| Site 178 | Anaheim | California | United States |
| Site 167 | Cerritos | California | United States |
| Site 189 | Cerritos | California | United States |
| Site 183 | Culver City | California | United States |
| Site 140 | Garden Grove | California | United States |
| Site 162 | La Palma | California | United States |
| Site 190 | Long Beach | California | United States |
| Site 173 | Oceanside | California | United States |
| Site 175 | Paramount | California | United States |
| Site 136 | Pasadena | California | United States |
| Site 184 | Sacramento | California | United States |
| Site 152 | San Diego | California | United States |
| Site 186 | San Diego | California | United States |
| Site 133 | Santa Ana | California | United States |
| Site 171 | Torrance | California | United States |
| Site 197 | Boca Raton | Florida | United States |
| Site 156 | Gainesville | Florida | United States |
| Site 188 | Hialeah | Florida | United States |
| Site 193 | Jacksonville | Florida | United States |
| Site 154 | Miami | Florida | United States |
| Site 163 | North Miami | Florida | United States |
| Site 168 | North Miami | Florida | United States |
| Site 166 | Orange City | Florida | United States |
| Site 124 | Orlando | Florida | United States |
| Site 187 | Tampa | Florida | United States |
| Site 161 | Atlanta | Georgia | United States |
| Site 128 | Augusta | Georgia | United States |
| Site 122 | Decatur | Georgia | United States |
| Site 174 | Chicago | Illinois | United States |
| Site 164 | Indianapolis | Indiana | United States |
| Site 172 | Lake Charles | Louisiana | United States |
| Site 182 | Shreveport | Louisiana | United States |
| Site 121 | Glen Burnie | Maryland | United States |
| Site 159 | Detroit | Michigan | United States |
| Site 153 | Minneapolis | Minnesota | United States |
| Site 145 | Saint Charles | Missouri | United States |
| Site 130 | St Louis | Missouri | United States |
| Site 141 | St Louis | Missouri | United States |
| Site 142 | Clementon | New Jersey | United States |
| Site 180 | Kenilworth | New Jersey | United States |
| Site 129 | Albuquerque | New Mexico | United States |
| Site 131 | Brooklyn | New York | United States |
| Site 181 | Cedarhurst | New York | United States |
| Site 169 | Jamaica | New York | United States |
| Site 195 | New York | New York | United States |
| Site 147 | Staten Island | New York | United States |
| Site 127 | Chagrin Falls | Ohio | United States |
| Site 176 | Cincinnati | Ohio | United States |
| Site 191 | Oklahoma City | Oklahoma | United States |
| Site 146 | Philadelphia | Pennsylvania | United States |
| Site 179 | Philadelphia | Pennsylvania | United States |
| Site 196 | Sioux Falls | South Dakota | United States |
| Site 134 | Memphis | Tennessee | United States |
| Site 170 | Memphis | Tennessee | United States |
| Site 177 | Austin | Texas | United States |
| Site 185 | Conroe | Texas | United States |
| Site 126 | Houston | Texas | United States |
| Site 151 | San Antonio | Texas | United States |
| Site 138 | Richmond | Virginia | United States |
| Site 198 | Spokane | Washington | United States |
| Site 165 | Huntington | West Virginia | United States |
| Site 302 | Buenos Aires | Argentina |
| Site 305 | Buenos Aires | Argentina |
| Site 306 | Córdoba | Argentina |
| Site 307 | La Plata | Argentina |
| Site 301 | Mendoza | Argentina |
| Site 304 | Mendoza | Argentina |
| Site 308 | Mendoza | Argentina |
| Site 303 | Rosario | Argentina |
| Site 116 | Chatham | Ontario | Canada |
| Site 117 | Mississauga | Ontario | Canada |
| Site 100 | Calgary | Canada |
| Site 101 | Claresholm | Canada |
| Site 110 | Halifax | Canada |
| Site 111 | Hull | Canada |
| Site 107 | Kelowna | Canada |
| Site 109 | Kingston | Canada |
| Site 115 | Markham | Canada |
| Site 112 | Medicine Hat | Canada |
| Site 108 | Orléans | Canada |
| Site 106 | Ottawa | Canada |
| Site 104 | Prince Albert | Canada |
| Site 102 | Sherbrooke | Canada |
| Site 114 | Victoria | Canada |
| Site 113 | Winnipeg | Canada |
| Site 235 | Bolonska | Czechia |
| Site 234 | Jablonova | Czechia |
| Site 216 | Litoměřice | Czechia |
| Site 233 | Na Markvartce | Czechia |
| Site 213 | Olomouc | Czechia |
| Site 214 | Pilsen | Czechia |
| Site 215 | Prague | Czechia |
| Site 217 | Prague | Czechia |
| Site 236 | Rejskovo Namesti | Czechia |
| Site 231 | Paldksi Mnt | Estonia |
| Site 229 | Tartu | Estonia |
| Site 230 | Võru | Estonia |
| Site 202 | Clermont-Ferrand | France |
| Site 203 | Dole | France |
| Site 201 | Saint-Cyr-au-Mont-d'Or | France |
| Site 206 | Balassagyarmat | Hungary |
| Site 204 | Budapest | Hungary |
| Site 205 | Budapest | Hungary |
| Site 208 | Budapest | Hungary |
| Site 211 | Budapest | Hungary |
| Site 207 | Debrecen | Hungary |
| Site 212 | Győr | Hungary |
| Site 209 | Gyula | Hungary |
| Site 210 | Pécs | Hungary |
| Site 219 | Balvi | Latvia |
| Site 221 | Jelgava | Latvia |
| Site 218 | Liepāja | Latvia |
| Site 222 | Riga | Latvia |
| Site 220 | Sigulda | Latvia |
| Site 225 | Kaunas | Lithuania |
| Site 226 | Kaunas | Lithuania |
| Site 223 | Klaipėda | Lithuania |
| Site 232 | Šilutė | Lithuania |
| Site 224 | Vilnius | Lithuania |
| Site 228 | Vilnius | Lithuania |
| 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 |
|---|---|
| D000068180 | Aripiprazole |
| D000077152 | Olanzapine |
| D018967 | Risperidone |
| D000069348 | Quetiapine Fumarate |
| C092292 | ziprasidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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