Status:
COMPLETED
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Lead Sponsor:
Janssen-Cilag Pty Ltd
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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...
Detailed Description
This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patie...
Eligibility Criteria
Inclusion
- Patients must satisfy the following criteria to be eligible for this study: patients with diagnoses of schizophrenia according to the DSM-IV criteria including newly diagnosed patients
- Out-patients or in-patients with expected discharge within 8 weeks
- Patients or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion
- Patients who meet any of the following criteria will be excluded from participating in the study: patients who are resistant to antipsychotic treatment
- Patients who have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months
- Patients with CGl-S scores \> 6 or who who have been hospitalized for longer than 8 continuous weeks during the past 6 months
- Pregnant or breast-feeding females
- Patients with a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00473434
Start Date
April 1 2007
End Date
August 1 2009
Last Update
December 5 2012
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