INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Paliperidone ER

• Registration Number: NCT00697658
• Lead Sponsor: Janssen-Cilag B.V.

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-16
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Patient meets the DSM-IV criteria for schizophrenia
• Switched to or started on paliperidone ER, not longer than two weeks ago
• In 24 hours before initiation of paliperidone ER treatment, CGI-S, patient satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available
• Patient or legal representative has signed the informed consent form within two weeks after starting treatment with paliperidone ER

Exclusion Criteria

• No use of paliperidone ER, clozapine, any conventional depot neuroleptic or long acting atypical antipsychotic drugs during 3 months before starting paliperidone ER
• No participation in an investigational drug trial in 30 days prior to starting paliperidone ER
• No history of neuroleptic malignant syndrome
• No known hypersensitivity to paliperidone ER or risperidone
• No patients hospitalized for a period longer than 12 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	Paliperidone ER	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in CGI-S score at the end of the study	Week 26 or drop out visit

Secondary Outcome Measures

Name	Time	Method
Change in GAF score	Week 26 or drop out visit
Patient satisfaction with treatment	Week 26 or drop out visit
Change in Health of the Nation Outcome Scales (HoNOS)	Week 26 or drop out visit