Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

Study Overview
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Brief Summary
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The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.

Detailed Description
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This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered

Official Title
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A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: paliperidone palmitate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV) Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry. Exclusion Criteria: Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 001<br>paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information. | Drug: paliperidone palmitate<br>* Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with symptomatic relapse |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S. |  | Up to 12 months | 
| Clinical effectiveness and social outcomes as measured by HoNOS. |  | Up to 12 months | 
| Clinical effectiveness and social outcomes as measured by PSP. |  | Up to 12 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Up to 12 months | 
| Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paliperidone palmitate, INVEGA SUSTENNA, registries, quality of healthcare, schizophrenia