Schizophrenia and Schizoaffective DisorderPhase 3NCT00347425
Switch Study of Existing Atypical Antipsychotics to Bifeprunox
A Phase 3 study testing Aripiprazole, Olanzapine and Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Solvay Pharmaceuticals at 122 sites in 9 countries.
Trial summary
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia and Schizoaffective Disorder
- What is being tested?
- Aripiprazole, Olanzapine and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 122 sitesin 9 countries
- Study dates
- Dec 2006to Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated
Who cannot join
- Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Trial locations and contacts
122 sites in 9 countries.
122 sites in 9 countries
United States63 sites
Site 129
Albuquerque, New Mexico
Site 178
Anaheim, California
Site 161
Atlanta, Georgia
Site 128
Augusta, Georgia
Site 177
Austin, Texas
Site 148
Birmingham, Alabama
Site 197
Boca Raton, Florida
Site 131
Brooklyn, New York
Site 181
Cedarhurst, New York
Site 167
Cerritos, California
Site 189
Cerritos, California
Site 127
Chagrin Falls, Ohio
Site 174
Chicago, Illinois
Site 176
Cincinnati, Ohio
Site 142
Clementon, New Jersey
Site 185
Conroe, Texas
Site 183
Culver City, California
Site 122
Decatur, Georgia
Site 159
Detroit, Michigan
Site 156
Gainesville, Florida
Site 140
Garden Grove, California
Site 121
Glen Burnie, Maryland
Site 188
Hialeah, Florida
Site 126
Houston, Texas
Site 165
Huntington, West Virginia
Site 164
Indianapolis, Indiana
Site 193
Jacksonville, Florida
Site 169
Jamaica, New York
Site 180
Kenilworth, New Jersey
Site 162
La Palma, California
Site 172
Lake Charles, Louisiana
Site 194
Little Rock, Arkansas
Site 190
Long Beach, California
Site 134
Memphis, Tennessee
Site 170
Memphis, Tennessee
Site 154
Miami, Florida
Site 153
Minneapolis, Minnesota
Site 195
New York, New York
Site 163
North Miami, Florida
Site 168
North Miami, Florida
Site 173
Oceanside, California
Site 191
Oklahoma City, Oklahoma
Site 166
Orange City, Florida
Site 124
Orlando, Florida
Site 175
Paramount, California
Site 136
Pasadena, California
Site 146
Philadelphia, Pennsylvania
Site 179
Philadelphia, Pennsylvania
Site 138
Richmond, Virginia
Site 184
Sacramento, California
Site 145
Saint Charles, Missouri
Site 151
San Antonio, Texas
Site 152
San Diego, California
Site 186
San Diego, California
Site 133
Santa Ana, California
Site 182
Shreveport, Louisiana
Site 196
Sioux Falls, South Dakota
Site 198
Spokane, Washington
Site 130
St Louis, Missouri
Site 141
St Louis, Missouri
Site 147
Staten Island, New York
Site 187
Tampa, Florida
Site 171
Torrance, California
Canada16 sites
Site 100
Calgary
Site 116
Chatham, Ontario
Site 101
Claresholm
Site 110
Halifax
Site 111
Hull
Site 107
Kelowna
Site 109
Kingston
Site 115
Markham
Site 112
Medicine Hat
Site 117
Mississauga, Ontario
Site 108
Orléans
Site 106
Ottawa
Site 104
Prince Albert
Site 102
Sherbrooke
Site 114
Victoria
Site 113
Winnipeg
Czechia9 sites
Site 235
Bolonska
Site 234
Jablonova
Site 216
Litoměřice
Site 233
Na Markvartce
Site 213
Olomouc
Site 214
Pilsen
Site 215
Prague
Site 217
Prague
Site 236
Rejskovo Namesti
Hungary9 sites
Site 206
Balassagyarmat
Site 204
Budapest
Site 205
Budapest
Site 208
Budapest
Site 211
Budapest
Site 207
Debrecen
Site 212
Győr
Site 209
Gyula
Site 210
Pécs
Argentina8 sites
Site 302
Buenos Aires
Site 305
Buenos Aires
Site 306
Córdoba
Site 307
La Plata
Site 301
Mendoza
Site 304
Mendoza
Site 308
Mendoza
Site 303
Rosario
Lithuania6 sites
Site 225
Kaunas
Site 226
Kaunas
Site 223
Klaipėda
Site 232
Šilutė
Site 224
Vilnius
Site 228
Vilnius
Latvia5 sites
Site 219
Balvi
Site 221
Jelgava
Site 218
Liepāja
Site 222
Riga
Site 220
Sigulda
France3 sites
Site 202
Clermont-Ferrand
Site 203
Dole
Site 201
Saint-Cyr-au-Mont-d'Or
About this study
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
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
- Being tested
- Aripiprazole, Olanzapine, Risperidone, Quetiapine, Ziprasidone
- Keywords
- Switch Study, Schizophrenia, Atypical Antipsychotics
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
OlanzapineDrug
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
RisperidoneDrug
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
QuetiapineDrug
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
ZiprasidoneDrug
Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox
AripiprazoleDrug
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
OlanzapineDrug
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
RisperidoneDrug
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
QuetiapineDrug
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
ZiprasidoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Not described Receives: Drug: Aripiprazole; Drug: Olanzapine; Drug: Risperidone; Drug: Quetiapine; Drug: Ziprasidone |
| B | Other | Not described Receives: Drug: Aripiprazole; Drug: Olanzapine; Drug: Risperidone; Drug: Quetiapine; Drug: Ziprasidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
Adverse events
Measured: 4 weeks
Adverse events
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startDec 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Schizoaffective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347425
- Sponsor's protocol ID
- S154.3.020
- Other IDs
- 2006-004972-11
- Status last verified
- May 2008
- First submitted
- 30 Jun 2006
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00347425
- Acronym / sponsor ID
- S154.3.020
- Keywords
- Switch Study, Schizophrenia, Atypical Antipsychotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Dec 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Aripiprazole, Drug: Olanzapine, Drug: Risperidone, Drug: Quetiapine, Drug: Ziprasidone |
| B | Other | Drug: Aripiprazole, Drug: Olanzapine, Drug: Risperidone, Drug: Quetiapine, Drug: Ziprasidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females, 18-65 years, meeting DSM-IV TR diagnosis of Schizophrenia or Schizoaffective Disorder for whom a switch is indicated
Key exclusion criteria (1 listed)
- Acutely psychotic or with a current Axis I primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder based on DSM-IV TR criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AripiprazoleAbrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox | Drug | A |
| OlanzapineAbrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox | Drug | A |
| RisperidoneAbrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox | Drug | A |
| QuetiapineAbrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox | Drug | A |
| ZiprasidoneAbrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox | Drug | A |
| AripiprazoleCross-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 | B |
| OlanzapineCross-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 | B |
| RisperidoneCross-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 | B |
| QuetiapineCross-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 | B |
| ZiprasidoneCross-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 | B |
Primary outcome
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
2 secondary outcomes
Adverse events
Time frame: 4 weeks
Adverse events
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
122 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole, Olanzapine and Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Solvay Pharmaceuticals at 122 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in United States, Canada, Czechia, Hungary, Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2008.