Switch Study of Existing Atypical Antipsychotics to Bifeprunox
- Conditions
- Schizophrenia and Schizoaffective Disorder
- Interventions
- Registration Number
- NCT00347425
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
- Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated
- Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Aripiprazole - A Olanzapine - A Risperidone - A Quetiapine - B Aripiprazole - B Olanzapine - B Risperidone - B Ziprasidone - A Ziprasidone - B Quetiapine -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Adverse events 26 weeks
Trial Locations
- Locations (122)
Site 180
🇺🇸Kenilworth, New Jersey, United States
Site 308
🇦🇷Mendoza, Argentina
Site 212
🇭🇺Gyor, Hungary
Site 210
🇭🇺Pecs, Hungary
Site 218
🇱🇻Liepaja, Latvia
Site 220
🇱🇻Sigulda, Latvia
Site 226
🇱🇹Kaunas, Lithuania
Site 228
🇱🇹Vilnius, Lithuania
Site 146
🇺🇸Philadelphia, Pennsylvania, United States
Site 117
🇨🇦Mississauga, Ontario, Canada
Site 154
🇺🇸Miami, Florida, United States
Site 164
🇺🇸Indianapolis, Indiana, United States
Site 176
🇺🇸Cincinnati, Ohio, United States
Site 213
🇨🇿Olomouc, Czech Republic
Site 215
🇨🇿Praha, Czech Republic
Site 107
🇨🇦Kelowna, Canada
Site 178
🇺🇸Anaheim, California, United States
Site 183
🇺🇸Culver City, California, United States
Site 173
🇺🇸Oceanside, California, United States
Site 102
🇨🇦Sherbrooke, Canada
Site 126
🇺🇸Houston, Texas, United States
Site 168
🇺🇸North Miami, Florida, United States
Site 121
🇺🇸Glen Burnie, Maryland, United States
Site 133
🇺🇸Santa Ana, California, United States
Site 186
🇺🇸San Diego, California, United States
Site 194
🇺🇸Little Rock, Arkansas, United States
Site 167
🇺🇸Cerritos, California, United States
Site 189
🇺🇸Cerritos, California, United States
Site 136
🇺🇸Pasadena, California, United States
Site 130
🇺🇸St. Louis, Missouri, United States
Site 145
🇺🇸St. Charles, Missouri, United States
Site 163
🇺🇸North Miami, Florida, United States
Site 131
🇺🇸Brooklyn, New York, United States
Site 171
🇺🇸Torrance, California, United States
Site 188
🇺🇸Hialeah, Florida, United States
Site 122
🇺🇸Decatur, Georgia, United States
Site 174
🇺🇸Chicago, Illinois, United States
Site 190
🇺🇸Long Beach, California, United States
Site 140
🇺🇸Garden Grove, California, United States
Site 181
🇺🇸Cedarhurst, New York, United States
Site 197
🇺🇸Boca Raton, Florida, United States
Site 147
🇺🇸Staten Island, New York, United States
Site 152
🇺🇸San Diego, California, United States
Site 182
🇺🇸Shreveport, Louisiana, United States
Site 175
🇺🇸Paramount, California, United States
Site 141
🇺🇸St. Louis, Missouri, United States
Site 128
🇺🇸Augusta, Georgia, United States
Site 159
🇺🇸Detroit, Michigan, United States
Site 193
🇺🇸Jacksonville, Florida, United States
Site 166
🇺🇸Orange City, Florida, United States
Site 202
🇫🇷Clermont Ferrand, France
Site 203
🇫🇷Dole, France
Site 234
🇨🇿Jablonova, Czech Republic
Site 214
🇨🇿Plzen, Czech Republic
Site 201
🇫🇷St. Cyr au Mont d Or, France
Site 204
🇭🇺Budapest, Hungary
Site 221
🇱🇻Jelgava, Latvia
Site 206
🇭🇺Balassagyarmat, Hungary
Site 205
🇭🇺Budapest, Hungary
Site 211
🇭🇺Budapest, Hungary
Site 153
🇺🇸Minneapolis, Minnesota, United States
Site 191
🇺🇸Oklahoma City, Oklahoma, United States
Site 148
🇺🇸Birmingham, Alabama, United States
Site 162
🇺🇸La Palma, California, United States
Site 151
🇺🇸San Antonio, Texas, United States
Site 106
🇨🇦Ottawa, Canada
Site 113
🇨🇦Winnipeg, Canada
Site 177
🇺🇸Austin, Texas, United States
Site 169
🇺🇸Jamaica, New York, United States
Site 161
🇺🇸Atlanta, Georgia, United States
Site 127
🇺🇸Chagrin Falls, Ohio, United States
Site 230
🇪🇪Voru, Estonia
Site 172
🇺🇸Lake Charles, Louisiana, United States
Site 195
🇺🇸New York, New York, United States
Site 170
🇺🇸Memphis, Tennessee, United States
Site 142
🇺🇸Clementon, New Jersey, United States
Site 134
🇺🇸Memphis, Tennessee, United States
Site 179
🇺🇸Philadelphia, Pennsylvania, United States
Site 196
🇺🇸Sioux Falls, South Dakota, United States
Site 185
🇺🇸Conroe, Texas, United States
Site 302
🇦🇷Buenos Aires, Argentina
Site 198
🇺🇸Spokane, Washington, United States
Site 165
🇺🇸Huntington, West Virginia, United States
Site 304
🇦🇷Mendoza, Argentina
Site 305
🇦🇷Buenos Aires, Argentina
Site 301
🇦🇷Mendoza, Argentina
Site 303
🇦🇷Rosario, Argentina
Site 306
🇦🇷Cordoba, Argentina
Site 307
🇦🇷La Plata, Argentina
Site 236
🇨🇿Rejskovo namesti, Czech Republic
Site 116
🇨🇦Chatham, Ontario, Canada
Site 100
🇨🇦Calgary, Canada
Site 112
🇨🇦Medicine Hat, Canada
Site 110
🇨🇦Halifax, Canada
Site 101
🇨🇦Claresholm, Canada
Site 109
🇨🇦Kingston, Canada
Site 108
🇨🇦Orleans, Canada
Site 115
🇨🇦Markham, Canada
Site 111
🇨🇦Hull, Canada
Site 104
🇨🇦Prince Albert, Canada
Site 216
🇨🇿Litomerice, Czech Republic
Site 233
🇨🇿Na Markvartce, Czech Republic
Site 114
🇨🇦Victoria, Canada
Site 235
🇨🇿Bolonska, Czech Republic
Site 217
🇨🇿Prague, Czech Republic
Site 231
🇪🇪Paldksi Mnt, Estonia
Site 229
🇪🇪Tartu, Estonia
Site 207
🇭🇺Debrecen, Hungary
Site 232
🇱🇹Silute, Lithuania
Site 209
🇭🇺Gyula, Hungary
Site 225
🇱🇹Kaunas, Lithuania
Site 208
🇭🇺Budapest, Hungary
Site 219
🇱🇻Balvi, Latvia
Site 222
🇱🇻Riga, Latvia
Site 224
🇱🇹Vilnius, Lithuania
Site 223
🇱🇹Klaipeda, Lithuania
Site 184
🇺🇸Sacramento, California, United States
Site 156
🇺🇸Gainesville, Florida, United States
Site 124
🇺🇸Orlando, Florida, United States
Site 187
🇺🇸Tampa, Florida, United States
Site 129
🇺🇸Albuquerque, New Mexico, United States
Site 138
🇺🇸Richmond, Virginia, United States