INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00697658|
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : April 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Paliperidone ER||Phase 4|
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.
|Study Type :||Observational|
|Actual Enrollment :||27 participants|
|Official Title:||INVega Is Studied In an Observational Design in the Netherlands|
|Study Start Date :||March 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||November 2009|
Drug: Paliperidone ER
6 mg tablet once daily, variable treatment length.
- Change from baseline in CGI-S score at the end of the study [ Time Frame: Week 26 or drop out visit ]
- Change in Health of the Nation Outcome Scales (HoNOS) [ Time Frame: Week 26 or drop out visit ]
- Change in GAF score [ Time Frame: Week 26 or drop out visit ]
- Patient satisfaction with treatment [ Time Frame: Week 26 or drop out visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697658
|Alphen Aan Den Rijn, Netherlands|
|Hoorn Nh, Netherlands|
|Study Director:||Janssen-Cilag B.V. Clinical Trial||Janssen-Cilag B.V.|