Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

Janssen-Cilag Pty Ltd127 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

127

Conditions

Schizophrenia

Interventions

paliperidone palmitateDRUG

Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (10)

Unnamed facility

Bendigo, Australia

Unnamed facility

Box Hill, Australia

Unnamed facility

Elizabeth Vale, Australia

Unnamed facility

Epping, Australia

Outcomes

Primary Outcomes

Number of patients with symptomatic relapse

Time frame: Up to 12 months

Secondary Outcomes

Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.

Time frame: Up to 12 months

Clinical effectiveness and social outcomes as measured by HoNOS.

Time frame: Up to 12 months

Clinical effectiveness and social outcomes as measured by PSP.

Time frame: Up to 12 months

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: Up to 12 months

Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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