INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
|First Received Date ICMJE||April 11, 2008|
|Last Updated Date||April 26, 2010|
|Start Date ICMJE||February 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Change from baseline in CGI-S score at the end of the study [ Time Frame: Week 26 or drop out visit ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00697658 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia|
|Official Title ICMJE||INVega Is Studied In an Observational Design in the Netherlands|
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
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.
|Intervention ICMJE||Drug: Paliperidone ER
6 mg tablet once daily, variable treatment length.
|Study Group/Cohort (s)||001
Intervention: Drug: Paliperidone ER
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||November 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00697658|
|Other Study ID Numbers ICMJE||CR014788, R076477SCH4017|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Associate Director Medical Affairs, Janssen-Cilag B.V., Netherlands|
|Study Sponsor ICMJE||Janssen-Cilag B.V.|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Janssen-Cilag B.V.|
|Verification Date||April 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP