Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362426
• Other study ID #: CR018013
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2011
• Last updated: March 9, 2016
• Start date: March 2011
• Est. completion date: May 2013

Study information

• Verified date: March 2016
• Source: Janssen-Cilag Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of HealthUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with symptomatic relapse		Up to 12 months	Yes
Secondary	Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.		Up to 12 months	No
Secondary	Clinical effectiveness and social outcomes as measured by HoNOS.		Up to 12 months	No
Secondary	Clinical effectiveness and social outcomes as measured by PSP.		Up to 12 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Up to 12 months	Yes
Secondary	Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF		Up to 12 months	No