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| ID | Type | Description | Link |
|---|---|---|---|
| R092670SCH4063 | Other Identifier | Janssen-Cilag Farmaceutica Ltda. |
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The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone Palmitate 1-month formulation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Schizophrenia | Participants diagnosed with schizophrenia who switched from oral antipsychotics (OAPs) to Paliperidone Palmitate 1-month formulation (PP1M), with available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment, and who switched to PP1M at least 6-months after it was available for reimbursement in Portugal will be observed. The primary data source for this study will be the medical records of each participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Antipsychotics (OAPs) | Drug | No study treatment will be administered as a part of this study. Participants will receive OAPs (such as olanzapine, risperidone, paliperidone, aripiprazole or quetiapine) as per their usual clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M Treatment | Mean number of schizophrenia-related hospital admissions occurred during 12 months of oral antipsychotics (OAP) treatment prior to initiation of Paliperidone Palmitate 1-Month Formulation (PP1M) treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants. | Approximately 12 months |
| Mean Number of Schizophrenia-Related Hospital Admissions Occurred During 12 Months After Initiation of PP1M Treatment | Mean number of schizophrenia-related hospital admissions occurred during 12 months after initiation of PP1M treatment will be reported. Mean number of Schizophrenia-related hospital admissions will be calculated as: number of hospital admissions divided by total number of participants. | Approximately 12 months |
| Mean Change of Schizophrenia-Related Hospital Admissions Between Periods | Mean change of schizophrenia-related hospital admissions occurred between periods (during 12 months of OAP treatment prior and 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M and During 12 Months After Initiation of PP1M Treatment for the Subgroup of Participants that Completed 12 Months of PP1M Treatment | Mean number of hospital admissions occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment for the subgroup of participants that completed 12 months of PP1M treatment will be reported. Mean number of hospital admissions will be calculated as: number of hospital admissions divided by total number of participants. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include ambulatory participants diagnosed with schizophrenia that switched from oral antipsychotics (OAPs) to paliperidone palmitate 1-month formulation (PP1M), and with available information concerning the annual schizophrenia-related hospitalizations before and after initiation of PP1M treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Farmaceutica Ltda. Clinical Trial | Janssen-Cilag Farmaceutica Ltda. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurobios , Instituto De Neurociências | Porto | 4200 - 117 | Portugal |
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| Paliperidone Palmitate 1-Month Formulation (PP1M) | Drug | No study treatment will be administered as a part of this study. Participants will receive PP1M as per their usual clinical practice. |
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| Approximately 24 months |
| Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants that Completed 12 Months of PP1M Treatment | Mean change of hospital admissions occurred for the subgroup of participants that completed 12 months of PP1M between periods (during 12 months of OAP treatment prior and after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Mean Number of Hospital Admissions Occurred During 12 Months of OAP Treatment Prior to PP1M and During 12 Months After Initiation of PP1M Treatment for the Subgroup of Participants that Discontinued Before Completing 12 Months of PP1M Treatment | Mean number of hospital admissions occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment for the subgroup of participants that discontinued before completing 12 months of PP1M treatment will be reported. Mean number of hospital admissions will be calculated as: number of hospital admissions divided by total number of participants. | Approximately 24 months |
| Mean Change of Hospital Admissions Between Periods for the Subgroup of Participants That Discontinued Before Completing 12 Months of PP1M Treatment | Mean change of hospital admissions occurred for the subgroup of participants that discontinued before completing 12 months of PP1M treatment between periods (during 12 months of OAP treatment prior and after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Mean Length of Hospitalizations | Mean length of hospitalizations occurred during 12 months after initiation of OAP treatment and the mean length of hospitalizations occurred during 12 months after initiation of PP1M treatment will be reported. | Approximately 24 months |
| Mean Change in Length of Hospitalizations Between Periods | Mean change in length of hospitalizations between periods (occurred during 12 months after initiation of OAP treatment and during 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Mean Cumulative Length of Hospitalizations | The mean cumulative length of hospitalizations occurred during 12 months after initiation of OAP treatment and the mean length of hospitalizations occurred during 12 months after initiation of PP1M treatment will be reported. | Approximately 24 months |
| Mean Change in Cumulative Length of Hospitalizations Between Periods | Mean change in cumulative length of hospitalizations between periods (occurred during 12 months after initiation of OAP treatment and during 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Hospitalization Rate per Patient-Years | The hospitalization rate per patient-year will be calculated as: Hospitalization rate per patient-years = Number of hospitalizations in the treatment period divided by total follow-up time in the treatment period where the total follow-up time corresponds to the cumulative follow-up time of all included participants in the treatment period. | Approximately 24 months |
| Mean Number of Emergency Psychiatric Visits | The mean number of emergency psychiatric visits occurred during 12 months of OAP treatment prior to PP1M and the mean number of emergency psychiatric visits occurred during 12 months after initiation of PP1M treatment will be reported. | Approximately 24 months |
| Mean Change in Emergency Psychiatric Visits Between Periods | Mean change in emergency psychiatric visits between periods (occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Percentage of Participants Hospitalized | Percentage of participants hospitalized during 12 months of OAP treatment prior to PP1M and the percentage of participants hospitalized during 12 months after initiation of PP1M treatment will be reported. | Approximately 24 months |
| Change in Percentages of Participants Hospitalized Between Periods (Hospitalization Reduction Percentage) | Change in percentage of participants hospitalized between periods (percentage of participants hospitalized during 12 months of OAP treatment prior to PP1M and the percentage of participants hospitalized during 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Percentage of Outpatient Psychiatric Consultations | Percentage of outpatient psychiatric consultations occurred during 12 months of OAP treatment prior to PP1M and the percentage of outpatient psychiatric consultations occurred during 12 months after initiation of PP1M treatment will be reported. | Approximately 24 months |
| Change in Percentage of Outpatient Psychiatric Consultations Between Periods | Change in percentage of outpatient psychiatric consultations between periods (occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Percentage of Relapse with Different Causes | Percentage of relapse with different causes occurred during 12 months of OAP treatment prior to PP1M and the percentage of relapse occurred during 12 months after initiation of PP1M treatment will be reported. | Approximately 24 months |
| Change in Percentages of Relapse Between Periods with Different Causes | Change in percentage of relapse between periods with different causes (occurred during 12 months of OAP treatment prior to PP1M and during 12 months after initiation of PP1M treatment) will be reported. | Approximately 24 months |
| Percentage of Participants who Discontinued PP1M Treatment with Different Reasons for Discontinuation Before and After Completing 12 Months of Treatment | Percentage of participants who discontinued PP1M treatment with different reasons for discontinuation (such as, lack of efficacy, tolerability issues or other) before and after completing 12 months of treatment will be reported. | Approximately 24 months |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014150 | Antipsychotic Agents |
| D000068882 | Paliperidone Palmitate |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D014149 | Tranquilizing Agents |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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