An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Information source: Janssen-Cilag Pty Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone (Drug)
Phase: Phase 3
Status: Completed
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
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
Secondary outcome: The Clinical Global Impression of Severity (CGI-S) Throughout the StudyThe Global Assessment of Functioning (GAF) Throughout the Study The Percentage of Participants Presenting Clinical Deterioration Throughout the Study The Number of Hospitalizations Throughout the Study The Length of Hospitalizations Throughout the Study
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
Additional Information
An open label multicentre study to determine the dose distribution of Paliperidone ER OROSĀ® in patients with schizophrenia
Starting date: April 2007
Last updated: December 4, 2012
|