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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.
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
Age
18 - 99 years
Sex
ALL
Healthy Volunteers
No
Bendigo, Australia
Box Hill, Australia
Elizabeth Vale, Australia
Epping, Australia
Fitzroy, Australia
Fremantle, Australia
Glenside, Australia
Meadowbrook, Australia
Waratah, Australia
Wollongong, Australia
Start Date
March 1, 2011
Primary Completion Date
May 1, 2013
Completion Date
May 1, 2013
Last Updated
March 10, 2016
127
ACTUAL participants
paliperidone palmitate
DRUG
Lead Sponsor
Janssen-Cilag Pty Ltd
NCT07455929
NCT06740383
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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