Switch Study of Existing Atypical Antipsychotics to Bifeprunox

Solvay

Status and phase: Completed; Phase 3

Conditions: Schizophrenia and Schizoaffective Disorder

Treatments: Drug: Risperidone; Drug: Olanzapine; Drug: Aripiprazole; Drug: Quetiapine; Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00347425

2006-004972-11

S154.3.020

Details and patient eligibility

About

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

Enrollment: 286 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

A

Other group

Treatment:

Drug: Risperidone

Drug: Quetiapine

Drug: Risperidone

Drug: Ziprasidone

Drug: Ziprasidone

Drug: Aripiprazole

Drug: Olanzapine

Drug: Olanzapine

Drug: Aripiprazole

Drug: Quetiapine

B

Other group

Treatment:

Drug: Risperidone

Drug: Quetiapine

Drug: Risperidone

Drug: Ziprasidone

Drug: Ziprasidone

Drug: Aripiprazole

Drug: Olanzapine

Drug: Olanzapine

Drug: Aripiprazole

Drug: Quetiapine