Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: paliperidone palmitate

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 Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• Australia
  • Bendigo, Australia
  • Box Hill, Australia
  • Elizabeth Vale, Australia
  • Epping, Australia
  • Fitzroy, Australia
  • Fremantle, Australia
  • Glenside, Australia
  • Meadowbrook, Australia
  • Waratah, Australia
  • Wollongong, Australia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Australian patients with schizophrenia will be enrolled in the registry

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001; paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.	Drug: paliperidone palmitate; Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Janssen-Cilag Pty Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 9, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: schizophrenia; paliperidone palmitate; INVEGA SUSTENNA; registries; quality of healthcare
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR018013