Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Solvay Pharmaceuticals286 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

286

Conditions

Schizophrenia and Schizoaffective Disorder

Interventions

AripiprazoleDRUG

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

OlanzapineDRUG

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

RisperidoneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (122)

Outcomes

Primary Outcomes

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

Secondary Outcomes

Adverse events

Time frame: 4 weeks

Adverse events

Time frame: 26 weeks

Data from ClinicalTrials.gov

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

ZiprasidoneDRUG

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

AripiprazoleDRUG