Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Study Overview
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Brief Summary
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The study will evaluate the safety and tolerability of switching subjects with schizophrenia or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.

Official Title
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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

Conditions
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Schizophrenia and Schizoaffective Disorder

Intervention / Treatment
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* Drug: Aripiprazole
* Drug: Olanzapine
* Drug: Risperidone
* Drug: Quetiapine
* Drug: Ziprasidone
* Drug: Aripiprazole
* Drug: Olanzapine
* Drug: Risperidone
* Drug: Quetiapine
* Drug: Ziprasidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 4 weeks | 
| Adverse events |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Switch Study, Schizophrenia, Atypical Antipsychotics