An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in
patients with schizophrenia who are switched from an oral atypical antipsychotic to
Paliperidone ER. In this study patients and physicians know the name and the dose of the
study drug. Newly diagnosed patients will also be included in the study. In general, the
recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a
higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can
be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was
chosen to best mimic actual clinical practice.The safety assessments to be conducted
throughout this study including the regular monitoring and recording of all Adverse Events
and Serious Adverse Events.