At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of schizophrenia per DSM-IV criteria, including newly diagnosed patients
- ✓Out-patients or in-patients with expected discharge within 8 weeks
- ✕Patients resistant to antipsychotic treatment
- ✕Clozapine or long-acting injectable antipsychotic use in the last 3 months
- ✕CGI-S score >6 or hospitalization >8 continuous weeks in past 6 months
- ✕History or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Paliperidone for Schizophrenia. Completed, enrolled 64 participants.
Detailed 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.
Study Details
Timeline
Interventions
3mg or 6mg or 9mg or 12mg once daily for 52 weeks