Schizophrenia and Schizoaffective Disorder Clinical Trial
Official title:
A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
Status | Completed |
Enrollment | 286 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated Exclusion Criteria: - Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Site 302 | Buenos Aires | |
Argentina | Site 305 | Buenos Aires | |
Argentina | Site 306 | Cordoba | |
Argentina | Site 307 | La Plata | |
Argentina | Site 301 | Mendoza | |
Argentina | Site 304 | Mendoza | |
Argentina | Site 308 | Mendoza | |
Argentina | Site 303 | Rosario | |
Canada | Site 100 | Calgary | |
Canada | Site 116 | Chatham | Ontario |
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 117 | Mississauga | Ontario |
Canada | Site 108 | Orleans | |
Canada | Site 106 | Ottawa | |
Canada | Site 104 | Prince Albert | |
Canada | Site 102 | Sherbrooke | |
Canada | Site 114 | Victoria | |
Canada | Site 113 | Winnipeg | |
Czech Republic | Site 235 | Bolonska | |
Czech Republic | Site 234 | Jablonova | |
Czech Republic | Site 216 | Litomerice | |
Czech Republic | Site 233 | Na Markvartce | |
Czech Republic | Site 213 | Olomouc | |
Czech Republic | Site 214 | Plzen | |
Czech Republic | Site 217 | Prague | |
Czech Republic | Site 215 | Praha | |
Czech Republic | Site 236 | Rejskovo namesti | |
Estonia | Site 231 | Paldksi Mnt | |
Estonia | Site 229 | Tartu | |
Estonia | Site 230 | Voru | |
France | Site 202 | Clermont Ferrand | |
France | Site 203 | Dole | |
France | Site 201 | St. Cyr au Mont d Or | |
Hungary | 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 | Gyor | |
Hungary | Site 209 | Gyula | |
Hungary | Site 210 | Pecs | |
Latvia | Site 219 | Balvi | |
Latvia | Site 221 | Jelgava | |
Latvia | Site 218 | Liepaja | |
Latvia | Site 222 | Riga | |
Latvia | Site 220 | Sigulda | |
Lithuania | Site 225 | Kaunas | |
Lithuania | Site 226 | Kaunas | |
Lithuania | Site 223 | Klaipeda | |
Lithuania | Site 232 | Silute | |
Lithuania | Site 224 | Vilnius | |
Lithuania | Site 228 | Vilnius | |
United States | Site 129 | Albuquerque | New Mexico |
United States | Site 178 | Anaheim | California |
United States | Site 161 | Atlanta | Georgia |
United States | Site 128 | Augusta | Georgia |
United States | Site 177 | Austin | Texas |
United States | Site 148 | Birmingham | Alabama |
United States | Site 197 | Boca Raton | Florida |
United States | Site 131 | Brooklyn | New York |
United States | Site 181 | Cedarhurst | New York |
United States | Site 167 | Cerritos | California |
United States | Site 189 | Cerritos | California |
United States | Site 127 | Chagrin Falls | Ohio |
United States | Site 174 | Chicago | Illinois |
United States | Site 176 | Cincinnati | Ohio |
United States | Site 142 | Clementon | New Jersey |
United States | Site 185 | Conroe | Texas |
United States | Site 183 | Culver City | California |
United States | Site 122 | Decatur | Georgia |
United States | Site 159 | Detroit | Michigan |
United States | Site 156 | Gainesville | Florida |
United States | Site 140 | Garden Grove | California |
United States | Site 121 | Glen Burnie | Maryland |
United States | Site 188 | Hialeah | Florida |
United States | Site 126 | Houston | Texas |
United States | Site 165 | Huntington | West Virginia |
United States | Site 164 | Indianapolis | Indiana |
United States | Site 193 | Jacksonville | Florida |
United States | Site 169 | Jamaica | New York |
United States | Site 180 | Kenilworth | New Jersey |
United States | Site 162 | La Palma | California |
United States | Site 172 | Lake Charles | Louisiana |
United States | Site 194 | Little Rock | Arkansas |
United States | Site 190 | Long Beach | California |
United States | Site 134 | Memphis | Tennessee |
United States | Site 170 | Memphis | Tennessee |
United States | Site 154 | Miami | Florida |
United States | Site 153 | Minneapolis | Minnesota |
United States | Site 195 | New York | New York |
United States | Site 163 | North Miami | Florida |
United States | Site 168 | North Miami | Florida |
United States | Site 173 | Oceanside | California |
United States | Site 191 | Oklahoma City | Oklahoma |
United States | Site 166 | Orange City | Florida |
United States | Site 124 | Orlando | Florida |
United States | Site 175 | Paramount | California |
United States | Site 136 | Pasadena | California |
United States | Site 146 | Philadelphia | Pennsylvania |
United States | Site 179 | Philadelphia | Pennsylvania |
United States | Site 138 | Richmond | Virginia |
United States | Site 184 | Sacramento | California |
United States | Site 151 | San Antonio | Texas |
United States | Site 152 | San Diego | California |
United States | Site 186 | San Diego | California |
United States | Site 133 | Santa Ana | California |
United States | Site 182 | Shreveport | Louisiana |
United States | Site 196 | Sioux Falls | South Dakota |
United States | Site 198 | Spokane | Washington |
United States | Site 145 | St. Charles | Missouri |
United States | Site 130 | St. Louis | Missouri |
United States | Site 141 | St. Louis | Missouri |
United States | Site 147 | Staten Island | New York |
United States | Site 187 | Tampa | Florida |
United States | Site 171 | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Solvay Pharmaceuticals | H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer |
United States, Argentina, Canada, Czech Republic, Estonia, France, Hungary, Latvia, Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Adverse events | 4 weeks | Yes | |
Secondary | Adverse events | 26 weeks | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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