Switch Study of Existing Atypical Antipsychotics to Bifeprunox

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

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

Sponsors & Collaborators

• H. Lundbeck A/S

  collaborator INDUSTRY

• Wyeth is now a wholly owned subsidiary of Pfizer

  collaborator INDUSTRY

• Solvay Pharmaceuticals

  lead INDUSTRY

Principal Investigators

• Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-12-31

Primary Completion

2008-02-29

Completion

2008-02-29

Countries

• United States
• Argentina
• Canada
• Czechia
• Estonia
• France
• Hungary
• Latvia
• Lithuania

Study Locations