An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia

Study Overview
=================
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 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.

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

Official Title
-----------------
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Paliperidone


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>Paliperidone3mg or 6mg or 9mg or 12mg once daily for 52 weeks | Drug: Paliperidone<br>* 3mg or 6mg or 9mg or 12mg once daily for 52 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 |  | Day 1 to Day 84 | 
| The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84 |  | Day 1 to Day 84 | 
| The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 |  | Day 57 to Day 84 | 
| The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84 |  | Day 57 to Day 84 | 
| The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 |  | Week 0 to Week 12 | 
| The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12 |  | Week 0 to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Clinical Global Impression of Severity (CGI-S) Throughout the Study | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients. | 52 weeks | 
| The Global Assessment of Functioning (GAF) Throughout the Study | The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death. | 52 Weeks | 
| The Percentage of Participants Presenting Clinical Deterioration Throughout the Study | This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms. | 52 Weeks | 
| The Number of Hospitalizations Throughout the Study | This outcome measure is intended to document all hospitalizations that occurred throughout the study. | 52 Weeks | 
| The Length of Hospitalizations Throughout the Study |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Drug Therapy, Treatment Outcome