Overview
INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
Status:
Completed
Completed
Trial end date:
2009-11-01
2009-11-01
Target enrollment:
0
0
Participant gender:
All
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?
NoDetails
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