Status:
COMPLETED
INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
Lead Sponsor:
Janssen-Cilag B.V.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
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 naturalist...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00697658
Start Date
March 1 2008
End Date
November 1 2009
Last Update
April 28 2014
Active Locations (17)
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1
Alphen aan den Rijn, Netherlands
2
Amersfoort, Netherlands
3
Amsterdam, Netherlands
4
Beverwijk, Netherlands