NCT01362426

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 127 (actual)
• Sponsor: Janssen-Cilag Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	paliperidone palmitate	Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-05-30
• Last updated: 2016-03-10

Locations

10 sites across 1 country: Australia