Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen-Cilag Pty Ltd
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
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
