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Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Primary Purpose

Schizophrenia and Schizoaffective Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Olanzapine
Risperidone
Quetiapine
Ziprasidone
Aripiprazole
Olanzapine
Risperidone
Quetiapine
Ziprasidone
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Schizoaffective Disorder focused on measuring Switch Study, Schizophrenia, Atypical Antipsychotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 148
  • Site 194
  • Site 178
  • Site 167
  • Site 189
  • Site 183
  • Site 140
  • Site 162
  • Site 190
  • Site 173
  • Site 175
  • Site 136
  • Site 184
  • Site 152
  • Site 186
  • Site 133
  • Site 171
  • Site 197
  • Site 156
  • Site 188
  • Site 193
  • Site 154
  • Site 163
  • Site 168
  • Site 166
  • Site 124
  • Site 187
  • Site 161
  • Site 128
  • Site 122
  • Site 174
  • Site 164
  • Site 172
  • Site 182
  • Site 121
  • Site 159
  • Site 153
  • Site 145
  • Site 130
  • Site 141
  • Site 142
  • Site 180
  • Site 129
  • Site 131
  • Site 181
  • Site 169
  • Site 195
  • Site 147
  • Site 127
  • Site 176
  • Site 191
  • Site 146
  • Site 179
  • Site 196
  • Site 134
  • Site 170
  • Site 177
  • Site 185
  • Site 126
  • Site 151
  • Site 138
  • Site 198
  • Site 165
  • Site 302
  • Site 305
  • Site 306
  • Site 307
  • Site 301
  • Site 304
  • Site 308
  • Site 303
  • Site 116
  • Site 117
  • Site 100
  • Site 101
  • Site 110
  • Site 111
  • Site 107
  • Site 109
  • Site 115
  • Site 112
  • Site 108
  • Site 106
  • Site 104
  • Site 102
  • Site 114
  • Site 113
  • Site 235
  • Site 234
  • Site 216
  • Site 233
  • Site 213
  • Site 214
  • Site 217
  • Site 215
  • Site 236
  • Site 231
  • Site 229
  • Site 230
  • Site 202
  • Site 203
  • Site 201
  • Site 206
  • Site 204
  • Site 205
  • Site 208
  • Site 211
  • Site 207
  • Site 212
  • Site 209
  • Site 210
  • Site 219
  • Site 221
  • Site 218
  • Site 222
  • Site 220
  • Site 225
  • Site 226
  • Site 223
  • Site 232
  • Site 224
  • Site 228

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse events
Adverse events

Full Information

First Posted
June 30, 2006
Last Updated
May 20, 2008
Sponsor
Solvay Pharmaceuticals
Collaborators
H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00347425
Brief Title
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

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals
Collaborators
H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Schizoaffective Disorder
Keywords
Switch Study, Schizophrenia, Atypical Antipsychotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Title
B
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
4 weeks
Title
Adverse events
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 148
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Site 194
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Site 178
City
Anaheim
State/Province
California
Country
United States
Facility Name
Site 167
City
Cerritos
State/Province
California
Country
United States
Facility Name
Site 189
City
Cerritos
State/Province
California
Country
United States
Facility Name
Site 183
City
Culver City
State/Province
California
Country
United States
Facility Name
Site 140
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Site 162
City
La Palma
State/Province
California
Country
United States
Facility Name
Site 190
City
Long Beach
State/Province
California
Country
United States
Facility Name
Site 173
City
Oceanside
State/Province
California
Country
United States
Facility Name
Site 175
City
Paramount
State/Province
California
Country
United States
Facility Name
Site 136
City
Pasadena
State/Province
California
Country
United States
Facility Name
Site 184
City
Sacramento
State/Province
California
Country
United States
Facility Name
Site 152
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 186
City
San Diego
State/Province
California
Country
United States
Facility Name
Site 133
City
Santa Ana
State/Province
California
Country
United States
Facility Name
Site 171
City
Torrance
State/Province
California
Country
United States
Facility Name
Site 197
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Site 156
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Site 188
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Site 193
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site 154
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 163
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Site 168
City
North Miami
State/Province
Florida
Country
United States
Facility Name
Site 166
City
Orange City
State/Province
Florida
Country
United States
Facility Name
Site 124
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Site 187
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site 161
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site 128
City
Augusta
State/Province
Georgia
Country
United States
Facility Name
Site 122
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
Site 174
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Site 164
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Site 172
City
Lake Charles
State/Province
Louisiana
Country
United States
Facility Name
Site 182
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Site 121
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Site 159
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Site 153
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Site 145
City
St. Charles
State/Province
Missouri
Country
United States
Facility Name
Site 130
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 141
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Site 142
City
Clementon
State/Province
New Jersey
Country
United States
Facility Name
Site 180
City
Kenilworth
State/Province
New Jersey
Country
United States
Facility Name
Site 129
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Site 131
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Site 181
City
Cedarhurst
State/Province
New York
Country
United States
Facility Name
Site 169
City
Jamaica
State/Province
New York
Country
United States
Facility Name
Site 195
City
New York
State/Province
New York
Country
United States
Facility Name
Site 147
City
Staten Island
State/Province
New York
Country
United States
Facility Name
Site 127
City
Chagrin Falls
State/Province
Ohio
Country
United States
Facility Name
Site 176
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 191
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 146
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 179
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 196
City
Sioux Falls
State/Province
South Dakota
Country
United States
Facility Name
Site 134
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Site 170
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Site 177
City
Austin
State/Province
Texas
Country
United States
Facility Name
Site 185
City
Conroe
State/Province
Texas
Country
United States
Facility Name
Site 126
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site 151
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site 138
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site 198
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Site 165
City
Huntington
State/Province
West Virginia
Country
United States
Facility Name
Site 302
City
Buenos Aires
Country
Argentina
Facility Name
Site 305
City
Buenos Aires
Country
Argentina
Facility Name
Site 306
City
Cordoba
Country
Argentina
Facility Name
Site 307
City
La Plata
Country
Argentina
Facility Name
Site 301
City
Mendoza
Country
Argentina
Facility Name
Site 304
City
Mendoza
Country
Argentina
Facility Name
Site 308
City
Mendoza
Country
Argentina
Facility Name
Site 303
City
Rosario
Country
Argentina
Facility Name
Site 116
City
Chatham
State/Province
Ontario
Country
Canada
Facility Name
Site 117
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Site 100
City
Calgary
Country
Canada
Facility Name
Site 101
City
Claresholm
Country
Canada
Facility Name
Site 110
City
Halifax
Country
Canada
Facility Name
Site 111
City
Hull
Country
Canada
Facility Name
Site 107
City
Kelowna
Country
Canada
Facility Name
Site 109
City
Kingston
Country
Canada
Facility Name
Site 115
City
Markham
Country
Canada
Facility Name
Site 112
City
Medicine Hat
Country
Canada
Facility Name
Site 108
City
Orleans
Country
Canada
Facility Name
Site 106
City
Ottawa
Country
Canada
Facility Name
Site 104
City
Prince Albert
Country
Canada
Facility Name
Site 102
City
Sherbrooke
Country
Canada
Facility Name
Site 114
City
Victoria
Country
Canada
Facility Name
Site 113
City
Winnipeg
Country
Canada
Facility Name
Site 235
City
Bolonska
Country
Czech Republic
Facility Name
Site 234
City
Jablonova
Country
Czech Republic
Facility Name
Site 216
City
Litomerice
Country
Czech Republic
Facility Name
Site 233
City
Na Markvartce
Country
Czech Republic
Facility Name
Site 213
City
Olomouc
Country
Czech Republic
Facility Name
Site 214
City
Plzen
Country
Czech Republic
Facility Name
Site 217
City
Prague
Country
Czech Republic
Facility Name
Site 215
City
Praha
Country
Czech Republic
Facility Name
Site 236
City
Rejskovo namesti
Country
Czech Republic
Facility Name
Site 231
City
Paldksi Mnt
Country
Estonia
Facility Name
Site 229
City
Tartu
Country
Estonia
Facility Name
Site 230
City
Voru
Country
Estonia
Facility Name
Site 202
City
Clermont Ferrand
Country
France
Facility Name
Site 203
City
Dole
Country
France
Facility Name
Site 201
City
St. Cyr au Mont d Or
Country
France
Facility Name
Site 206
City
Balassagyarmat
Country
Hungary
Facility Name
Site 204
City
Budapest
Country
Hungary
Facility Name
Site 205
City
Budapest
Country
Hungary
Facility Name
Site 208
City
Budapest
Country
Hungary
Facility Name
Site 211
City
Budapest
Country
Hungary
Facility Name
Site 207
City
Debrecen
Country
Hungary
Facility Name
Site 212
City
Gyor
Country
Hungary
Facility Name
Site 209
City
Gyula
Country
Hungary
Facility Name
Site 210
City
Pecs
Country
Hungary
Facility Name
Site 219
City
Balvi
Country
Latvia
Facility Name
Site 221
City
Jelgava
Country
Latvia
Facility Name
Site 218
City
Liepaja
Country
Latvia
Facility Name
Site 222
City
Riga
Country
Latvia
Facility Name
Site 220
City
Sigulda
Country
Latvia
Facility Name
Site 225
City
Kaunas
Country
Lithuania
Facility Name
Site 226
City
Kaunas
Country
Lithuania
Facility Name
Site 223
City
Klaipeda
Country
Lithuania
Facility Name
Site 232
City
Silute
Country
Lithuania
Facility Name
Site 224
City
Vilnius
Country
Lithuania
Facility Name
Site 228
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Learn more about this trial

Switch Study of Existing Atypical Antipsychotics to Bifeprunox

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