Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

Completed

• Conditions: Schizophrenia
• Interventions: Drug: paliperidone palmitate

• Registration Number: NCT01362426
• Lead Sponsor: Janssen-Cilag Pty Ltd

Brief Summary

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

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-30
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-09
• Last Update Posted: 2016-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	paliperidone palmitate	paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

Primary Outcome Measures

Name	Time	Method
Number of patients with symptomatic relapse	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
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 HoNOS.	Up to 12 months
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 the following clinical assessment tools: GAF	Up to 12 months