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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00347425

Enrollment

286

Registered

2006-07-04

Start date

2006-12-31

Completion date

2008-02-29

Last updated

2008-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia and Schizoaffective Disorder

Keywords

Switch Study, Schizophrenia, Atypical Antipsychotics

Brief summary

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

Interventions

DRUGAripiprazole

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

DRUGOlanzapine

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

DRUGRisperidone

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

DRUGQuetiapine

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

DRUGZiprasidone

Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox

Sponsors

H. Lundbeck A/S

CollaboratorINDUSTRY

Wyeth is now a wholly owned subsidiary of Pfizer

CollaboratorINDUSTRY

Solvay Pharmaceuticals

Lead SponsorINDUSTRY

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Adverse events	4 weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026