Switch Study of Existing Atypical Antipsychotics to Bifeprunox - Full Text View

Purpose

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

Condition	Intervention	Phase
Schizophrenia and Schizoaffective Disorder	Drug: Aripiprazole Drug: Olanzapine Drug: Risperidone Drug: Quetiapine Drug: Ziprasidone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Ziprasidone hydrochloride Aripiprazole Olanzapine Ziprasidone Ziprasidone mesylate Olanzapine pamoate

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	286
Study Start Date:	December 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
B	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

Arms

Assigned Interventions

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

B

Drug: Aripiprazole