Clinical Trials/NCT00347425

NCT00347425

Completed

Phase 3

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

Solvay Pharmaceuticals122 sites in 1 country286 target enrollmentDecember 2006

ConditionsSchizophrenia and Schizoaffective Disorder

InterventionsAripiprazole Olanzapine Risperidone Quetiapine Ziprasidone

DrugsAripiprazole Olanzapine Risperidone Quetiapine Ziprasidone

Overview

Phase: Phase 3
Intervention: Aripiprazole
Conditions: Schizophrenia and Schizoaffective Disorder
Sponsor: Solvay Pharmaceuticals
Enrollment: 286
Locations: 122
Primary Endpoint: 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.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

February 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solvay Pharmaceuticals

Eligibility Criteria

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

Arms & Interventions

A

Intervention: Aripiprazole

A

Intervention: Olanzapine

A

Intervention: Risperidone

A

Intervention: Quetiapine

A

Intervention: Ziprasidone

B

Intervention: Aripiprazole

B

Intervention: Olanzapine

B

Intervention: Risperidone

B

Intervention: Quetiapine

B

Intervention: Ziprasidone

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