Overview

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

Status:
Completed
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag B.V.
Treatments:
Paliperidone Palmitate
Criteria
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