Bifeprunox Extension to Extension Study in Patients With Schizophrenia

An Open-label Safety Study of Bifeprunox Investigating Flexible Doses of 20, 30, or 40mg/Day in Patients With Schizophrenia Who Have Completed Studies 10206 or 10265

The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.

This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.

Inclusion Criteria:

• Patients, suffering from schizophrenia, having completed studies 10206 or 10265
• Otherwise healthy
• Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception
• The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)

Exclusion Criteria:

• Current Axis I primary psychiatric diagnosis other than schizophrenia
• Significant risk of suicide and/or violent behaviour
• Other psychiatric, neurological or behavioural disorders that may interfere with study conduct
• Substance or alcohol abuse, current cannabis dependence
• Clinically significant physical illness