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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paliperidone palmitate | Drug | Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with symptomatic relapse | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S. | Up to 12 months | |
| Clinical effectiveness and social outcomes as measured by HoNOS. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Australian patients with schizophrenia will be enrolled in the registry
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Pty Ltd Clinical Trial | Janssen-Cilag Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bendigo | Australia | |||||
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Clinical effectiveness and social outcomes as measured by PSP. | Up to 12 months |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Up to 12 months |
| Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF | Up to 12 months |
| Box Hill |
| Australia |
| Elizabeth Vale | Australia |
| Epping | Australia |
| Fitzroy | Australia |
| Fremantle | Australia |
| Glenside | Australia |
| Meadowbrook | Australia |
| Waratah | Australia |
| Wollongong | Australia |
| D011743 |
| Pyrimidines |