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| ID | Type | Description | Link |
|---|---|---|---|
| R092670SCH4041 | Other Identifier | Janssen Pharmaceutica NV |
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The primary objective of this study is to explore hospitalization (number, length and reasons for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants during the first 12 months of treatment with once monthly paliperidone palmitate in naturalistic clinical settings.
This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate. Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected. The study will be conducted in countries within the EMEA region in which paliperidone palmitate is approved and available. The study will be considered complete with the last data collection for the last participant participating in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Schizophrenia | This is a retrospective, non-interventional, multicenter study to retrospectively evaluate hospitalization and medical resource use, patterns of paliperidone palmitate use, and clinical outcomes documented within the medical records of young, adult, newly diagnosed schizophrenia participants for the first 12 months of continuous treatment with paliperidone palmitate. Only retrospective data available from clinical routine practice and documented in a participant's medical record will be collected. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Patterns of paliperidone palmitate as measured by patient records | 12 months | |
| Treatment response Based on clinical illness, symptom severity and measurements of functioning Score | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with Schizophrenia (according to ICD 10 or DSM IV) who were recently diagnosed (<= 1 year [y] before start of PP treatment) with >= 18 y and <=29 y of age and who received PP for at least 12 months prior to study start of the study (retrospective cohort).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Janssen Pharmaceutica N.V., Belgium | Janssen Pharmaceutica N.V., Belgium | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijeka | Croatia | |||||
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Parameters of Psychosocial Functioning based on questionnaire | 12 months |
| Medical Resource Utilization | 12 months |
| Psychiatric hospitalizations preceding the first paliperidone palmitate injection | 12 months |
| Number of Participants with Adverse Events | 12 months |
| Split |
| Croatia |
| Zagreb | Croatia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Ankara | Turkey (Türkiye) |
| Denizli | Turkey (Türkiye) |