Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag Pty Ltd
• Treatments: Paliperidone Palmitate

Criteria

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.