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Sponsored by: |
Janssen-Cilag B.V. |
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Information provided by: | Janssen-Cilag B.V. |
ClinicalTrials.gov Identifier: | NCT00697658 |
The purpose of this study is to explore efficacy, tolerability and safety of paliperidone ER in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.
Study Type: | Observational |
Official Title: | INVega Is Studied In an Observational Design in the Netherlands. |
Estimated Enrollment: | 250 |
Study Start Date: | February 2008 |
This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone ER in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in 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;To explore possible association between CGI-S, GAF and HoNOS.
The patients will receive paliperidone ER (6 mg, 9 mg or other dosages within 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 SmPC.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Netherlands | |
Recruiting | |
Beverwijk, Netherlands | |
Recruiting | |
Purmerend, Netherlands | |
Recruiting | |
Zaandam, Netherlands, 1502 DV | |
Recruiting | |
Amstelveen, Netherlands | |
Recruiting | |
Alphen Aan Den Rijn, Netherlands | |
Recruiting | |
Amsterdam, Netherlands | |
Recruiting | |
Terneuzen, Netherlands, 4531GL | |
Recruiting | |
Kloetinge, Netherlands, 4481PM | |
Recruiting | |
Geldrop, Netherlands, 5664 EH | |
Recruiting | |
Echt, Netherlands | |
Recruiting | |
Tilburg, Netherlands, 5042 AD | |
Recruiting | |
Deventer, Netherlands | |
Recruiting | |
Amersfoort, Netherlands, 3816 CP | |
Recruiting | |
Blaricum, Netherlands, 1261 AN | |
Recruiting | |
Ede Gld, Netherlands, 6716 RR | |
Recruiting | |
Vlaardingen, Netherlands | |
Recruiting | |
Doetinchem, Netherlands | |
Recruiting | |
Roermond, Netherlands, 6042BL | |
Recruiting | |
Kampen, Netherlands | |
Recruiting | |
Hoorn Nh, Netherlands | |
Recruiting | |
Groningen, Netherlands | |
Recruiting | |
Heerenveen, Netherlands, 8441NC | |
Recruiting | |
Venray, Netherlands, 5803 AC | |
Recruiting | |
Heerde, Netherlands |
Study Director: | Janssen-Cilag B.V. Clinical Trial | Janssen-Cilag B.V. |
Study ID Numbers: | CR014788 |
Study First Received: | April 11, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00697658 |
Health Authority: | Netherlands: Netherlands Medicines Evaluation Board |
paliperidone ER Schizophrenia |
Schizophrenia Mental Disorders Risperidone |
9-hydroxy-risperidone Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |