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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.
First Received: May 11, 2007   Last Updated: October 2, 2009   History of Changes
Sponsor: Janssen-Cilag Pty Ltd
Information provided by: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT00473434
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: April 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: Paliperidone
3mg or 6mg or 9mg or 12mg once daily for 52 weeks

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 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473434

Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: Janssen-Cilag Pty Ltd ( Executive Director, Medical and Scientific Affairs )
Study ID Numbers: CR013213, R076477SCH3021
Study First Received: May 11, 2007
Last Updated: October 2, 2009
ClinicalTrials.gov Identifier: NCT00473434     History of Changes
Health Authority: Australia: Department of Health

Keywords provided by Janssen-Cilag Pty Ltd:
Schizophrenia
Drug Therapy
Treatment Outcome

Additional relevant MeSH terms:
Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 30, 2009