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An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
This study has been completed.
Study NCT00473434   Information provided by Janssen-Cilag Pty Ltd
First Received: May 11, 2007   Last Updated: October 2, 2009   History of Changes

May 11, 2007
October 2, 2009
April 2007
August 2009   (final data collection date for primary outcome measure)
The primary endpoint is the mean modal prescribed daily dose of paliperidone from Day 1 to Day 84 inclusive of the study. [ Time Frame: Day 1 to Day 84 ] [ Designated as safety issue: No ]
The primary endopoint is the mean modal prescribed daily dose of paliperidone from Day 1 to Day 84 inclusive of the study.
Complete list of historical versions of study NCT00473434 on ClinicalTrials.gov Archive Site
To assess the clinical efficacy (CGI and GAF) of Paliperidone ER over the duration of the study.To evaluate the safety of Paliperidone ER over the duration of the study.To assess the long-term (2-year) treatment outcomes of Paliperidone ER. [ Time Frame: Over the duration of the study ] [ Designated as safety issue: No ]
To assess the clinical efficacy (CGI and GAF) of Paliperidone ER over the duration of the study.To evaluate the safety of Paliperiodone ER over the duration of the study.To assess the long-term (2-year) treatment oucomes of Paliperidone ER.
 
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia

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.

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 patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. 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 study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2, 4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a full psychiatric history, demographic data and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will be performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons; clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence and adverse event reporting. Physical examinations will be performed periodically. Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral administration. 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. The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase

Phase III
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Schizophrenia
Drug: Paliperidone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
64
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00473434
Executive Director, Medical and Scientific Affairs, Janssen-Cilag Pty Ltd
CR013213, R076477SCH3021
Janssen-Cilag Pty Ltd
 
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP