Clinical trial NCT00347425: Switch Study of Existing Atypical Antipsychotics to Bifeprunox
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia and Schizoaffective Disorder
Keywords: Switch Study
Schizophrenia
Atypical Antipsychotics
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-07-04
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 148
state: Alabama
city: Little Rock
country: United States
facility: Site 194
state: Arkansas
city: Anaheim
country: United States
facility: Site 178
state: California
city: Cerritos
country: United States
facility: Site 167
state: California
city: Cerritos
country: United States
facility: Site 189
state: California
city: Culver City
country: United States
facility: Site 183
state: California
city: Garden Grove
country: United States
facility: Site 140
state: California
city: La Palma
country: United States
facility: Site 162
state: California
city: Long Beach
country: United States
facility: Site 190
state: California
city: Oceanside
country: United States
facility: Site 173
state: California
city: Paramount
country: United States
facility: Site 175
state: California
city: Pasadena
country: United States
facility: Site 136
state: California
city: Sacramento
country: United States
facility: Site 184
state: California
city: San Diego
country: United States
facility: Site 152
state: California
city: San Diego
country: United States
facility: Site 186
state: California
city: Santa Ana
country: United States
facility: Site 133
state: California
city: Torrance
country: United States
facility: Site 171
state: California
city: Boca Raton
country: United States
facility: Site 197
state: Florida
city: Gainesville
country: United States
facility: Site 156
state: Florida
city: Hialeah
country: United States
facility: Site 188
state: Florida
city: Jacksonville
country: United States
facility: Site 193
state: Florida
city: Miami
country: United States
facility: Site 154
state: Florida
city: North Miami
country: United States
facility: Site 163
state: Florida
city: North Miami
country: United States
facility: Site 168
state: Florida
city: Orange City
country: United States
facility: Site 166
state: Florida
city: Orlando
country: United States
facility: Site 124
state: Florida
city: Tampa
country: United States
facility: Site 187
state: Florida
city: Atlanta
country: United States
facility: Site 161
state: Georgia
city: Augusta
country: United States
facility: Site 128
state: Georgia
city: Decatur
country: United States
facility: Site 122
state: Georgia
city: Chicago
country: United States
facility: Site 174
state: Illinois
city: Indianapolis
country: United States
facility: Site 164
state: Indiana
city: Lake Charles
country: United States
facility: Site 172
state: Louisiana
city: Shreveport
country: United States
facility: Site 182
state: Louisiana
city: Glen Burnie
country: United States
facility: Site 121
state: Maryland
city: Detroit
country: United States
facility: Site 159
state: Michigan
city: Minneapolis
country: United States
facility: Site 153
state: Minnesota
city: St. Charles
country: United States
facility: Site 145
state: Missouri
city: St. Louis
country: United States
facility: Site 130
state: Missouri
city: St. Louis
country: United States
facility: Site 141
state: Missouri
city: Clementon
country: United States
facility: Site 142
state: New Jersey
city: Kenilworth
country: United States
facility: Site 180
state: New Jersey
city: Albuquerque
country: United States
facility: Site 129
state: New Mexico
city: Brooklyn
country: United States
facility: Site 131
state: New York
city: Cedarhurst
country: United States
facility: Site 181
state: New York
city: Jamaica
country: United States
facility: Site 169
state: New York
city: New York
country: United States
facility: Site 195
state: New York
city: Staten Island
country: United States
facility: Site 147
state: New York
city: Chagrin Falls
country: United States
facility: Site 127
state: Ohio
city: Cincinnati
country: United States
facility: Site 176
state: Ohio
city: Oklahoma City
country: United States
facility: Site 191
state: Oklahoma
city: Philadelphia
country: United States
facility: Site 146
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site 179
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Site 196
state: South Dakota
city: Memphis
country: United States
facility: Site 134
state: Tennessee
city: Memphis
country: United States
facility: Site 170
state: Tennessee
city: Austin
country: United States
facility: Site 177
state: Texas
city: Conroe
country: United States
facility: Site 185
state: Texas
city: Houston
country: United States
facility: Site 126
state: Texas
city: San Antonio
country: United States
facility: Site 151
state: Texas
city: Richmond
country: United States
facility: Site 138
state: Virginia
city: Spokane
country: United States
facility: Site 198
state: Washington
city: Huntington
country: United States
facility: Site 165
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Site 302
city: Buenos Aires
country: Argentina
facility: Site 305
city: Cordoba
country: Argentina
facility: Site 306
city: La Plata
country: Argentina
facility: Site 307
city: Mendoza
country: Argentina
facility: Site 301
city: Mendoza
country: Argentina
facility: Site 304
city: Mendoza
country: Argentina
facility: Site 308
city: Rosario
country: Argentina
facility: Site 303
city: Chatham
country: Canada
facility: Site 116
state: Ontario
city: Mississauga
country: Canada
facility: Site 117
state: Ontario
city: Calgary
country: Canada
facility: Site 100
city: Claresholm
country: Canada
facility: Site 101
city: Halifax
country: Canada
facility: Site 110
city: Hull
country: Canada
facility: Site 111
city: Kelowna
country: Canada
facility: Site 107
city: Kingston
country: Canada
facility: Site 109
city: Markham
country: Canada
facility: Site 115
city: Medicine Hat
country: Canada
facility: Site 112
city: Orleans
country: Canada
facility: Site 108
city: Ottawa
country: Canada
facility: Site 106
city: Prince Albert
country: Canada
facility: Site 104
city: Sherbrooke
country: Canada
facility: Site 102
city: Victoria
country: Canada
facility: Site 114
city: Winnipeg
country: Canada
facility: Site 113
city: Bolonska
country: Czech Republic
facility: Site 235
city: Jablonova
country: Czech Republic
facility: Site 234
city: Litomerice
country: Czech Republic
facility: Site 216
city: Na Markvartce
country: Czech Republic
facility: Site 233
city: Olomouc
country: Czech Republic
facility: Site 213
city: Plzen
country: Czech Republic
facility: Site 214
city: Prague
country: Czech Republic
facility: Site 217
city: Praha
country: Czech Republic
facility: Site 215
city: Rejskovo namesti
country: Czech Republic
facility: Site 236
city: Paldksi Mnt
country: Estonia
facility: Site 231
city: Tartu
country: Estonia
facility: Site 229
city: Voru
country: Estonia
facility: Site 230
city: Clermont Ferrand
country: France
facility: Site 202
city: Dole
country: France
facility: Site 203
city: St. Cyr au Mont d Or
country: France
facility: Site 201
city: Balassagyarmat
country: Hungary
facility: Site 206
city: Budapest
country: Hungary
facility: Site 204
city: Budapest
country: Hungary
facility: Site 205
city: Budapest
country: Hungary
facility: Site 208
city: Budapest
country: Hungary
facility: Site 211
city: Debrecen
country: Hungary
facility: Site 207
city: Gyor
country: Hungary
facility: Site 212
city: Gyula
country: Hungary
facility: Site 209
city: Pecs
country: Hungary
facility: Site 210
city: Balvi
country: Latvia
facility: Site 219
city: Jelgava
country: Latvia
facility: Site 221
city: Liepaja
country: Latvia
facility: Site 218
city: Riga
country: Latvia
facility: Site 222
city: Sigulda
country: Latvia
facility: Site 220
city: Kaunas
country: Lithuania
facility: Site 225
city: Kaunas
country: Lithuania
facility: Site 226
city: Klaipeda
country: Lithuania
facility: Site 223
city: Silute
country: Lithuania
facility: Site 232
city: Vilnius
country: Lithuania
facility: Site 224
city: Vilnius
country: Lithuania
facility: Site 228
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: