Switch Study of Existing Atypical Antipsychotics to Bifeprunox

May 20, 2008 updated by: Solvay Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
Drug: Aripiprazole
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Olanzapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Risperidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Quetiapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Ziprasidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Aripiprazole
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
Drug: Olanzapine
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
Drug: Risperidone
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
Drug: Quetiapine
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
Drug: Ziprasidone
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
Other: B
Drug: Aripiprazole
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Olanzapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Risperidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Quetiapine
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Ziprasidone
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
Drug: Aripiprazole
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
Drug: Olanzapine
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
Drug: Risperidone
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
Drug: Quetiapine
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
Drug: Ziprasidone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 26 weeks
26 weeks
Adverse events
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
H. Lundbeck A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2008

Last Update Submitted That Met QC Criteria

May 20, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S154.3.020
  • 2006-004972-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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