Switch Study of Existing Atypical Antipsychotics to Bifeprunox
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
2 other identifiers
interventional
286
9 countries
122
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2006
Shorter than P25 for phase_3
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedMay 21, 2008
May 1, 2008
1.2 years
June 30, 2006
May 20, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Adverse events
4 weeks
Adverse events
26 weeks
Study Arms (2)
A
OTHERB
OTHERInterventions
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Eligibility Criteria
You may qualify if:
- Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated
You may not qualify if:
- Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Solvay Pharmaceuticalslead
- H. Lundbeck A/Scollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (122)
Site 148
Birmingham, Alabama, United States
Site 194
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2006
First Posted
July 4, 2006
Study Start
December 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 21, 2008
Record last verified: 2008-05