An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Information source: Janssen-Cilag Pty Ltd
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone ER OROS (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Janssen-Cilag Pty Ltd Official(s) and/or principal investigator(s):
Janssen-Cilag Pty Ltd Clinical Trial, Study Director, Affiliation: Janssen-Cilag Pty Ltd
Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
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.
Clinical Details
Official title: An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: The primary endpoint is the mean modal prescribed daily dose of paliperidone from Day 1 to Day 84 inclusive of the study.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com
Frankston 3199, Australia; Recruiting
Elizabeth Vale 5112, Australia; Recruiting
Melbourne 3004, Australia; Recruiting
Dandenong 3175, Australia; Recruiting
Glenside 5065, Australia; Recruiting
Southport 4215, Australia; Recruiting
Hornsby 2077, Australia; Recruiting
Additional Information
To learn how to participate in this trial please click here.
Starting date: April 2007
Last updated: October 31, 2008
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