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

Schizophrenia Clinical Trial

Official title:

INVega Is Studied In an Observational Design in the Netherlands

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697658
• Other study ID #: CR014788
• Secondary ID: R076477SCH4017
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2008
• Last updated: April 24, 2014
• Start date: March 2008
• Est. completion date: November 2009

Study information

• Verified date: April 2014
• Source: Janssen-Cilag B.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Netherlands Medicines Evaluation Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Paliperidone ER
6 mg tablet once daily, variable treatment length.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in CGI-S score at the end of the study		Week 26 or drop out visit	No
Secondary	Change in Health of the Nation Outcome Scales (HoNOS)		Week 26 or drop out visit	No
Secondary	Change in GAF score		Week 26 or drop out visit	No
Secondary	Patient satisfaction with treatment		Week 26 or drop out visit	No