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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH4017 |
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The purpose of this study is to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.
This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline up to 26 weeks, in subgroups of schizophrenia patients who started treatment with paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social functioning based on routine outcome assessments in the Netherlands, the Health of the Nation Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction with treatment, changes in number of ambulant contacts, changes in body weight, changes in concomitant therapy and to explore adverse events in schizophrenia patients who started treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and HoNOS.
The patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients receive will be at the discretion of the investigator and according the Summary of Product Characteristics (SmPC). Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | 6 mg tablet once daily, variable treatment length. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CGI-S score at the end of the study | Week 26 or drop out visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health of the Nation Outcome Scales (HoNOS) | Week 26 or drop out visit | |
| Change in GAF score | Week 26 or drop out visit | |
| Patient satisfaction with treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Schizophrenia patients meeting DSM-IV criteria receiving paliperidone ER, as part of the common practice of participating physicians. Patients may enter the study as soon as their paliperidone ER treatment starts or when it has been less than 14 days after their treatment start.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag B.V. Clinical Trial | Janssen-Cilag B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alphen aan den Rijn | Netherlands | |||||
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| Week 26 or drop out visit |
| Amersfoort |
| Netherlands |
| Amsterdam | Netherlands |
| Beverwijk | Netherlands |
| Deventer | Netherlands |
| Echt | Netherlands |
| Enschede | Netherlands |
| Geldrop | Netherlands |
| Heerde | Netherlands |
| Heerenveen | Netherlands |
| Hoorn | Netherlands |
| Kampen | Netherlands |
| Nijmegen | Netherlands |
| Purmerend | Netherlands |
| Roermond | Netherlands |
| Vlaardingen | Netherlands |
| Zwolle | Netherlands |
| 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 |
| D011743 | Pyrimidines |
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