NCT00347425

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Schizophrenia and Schizoaffective Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2006-07-04
• Last updated: 2008-05-21

Locations

122 sites across 9 countries: United States, Argentina, Canada, Czechia, Estonia, France, Hungary, Latvia, Lithuania