INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
INVega Is Studied In an Observational Design in the Netherlands
2 other identifiers
observational
27
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2008
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedApril 28, 2014
April 1, 2014
1.7 years
April 11, 2008
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in CGI-S score at the end of the study
Week 26 or drop out visit
Secondary Outcomes (3)
Change in Health of the Nation Outcome Scales (HoNOS)
Week 26 or drop out visit
Change in GAF score
Week 26 or drop out visit
Patient satisfaction with treatment
Week 26 or drop out visit
Study Arms (1)
001
Interventions
Eligibility Criteria
Schizophrenia patients meeting DSM-IV criteria receiving paliperidone ER, as part of the common practice of participating physicians. Patients may enter the study as soon as their paliperidone ER treatment starts or when it has been less than 14 days after their treatment start.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Alphen aan den Rijn, Netherlands
Unknown Facility
Amersfoort, Netherlands
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Beverwijk, Netherlands
Unknown Facility
Deventer, Netherlands
Unknown Facility
Echt, Netherlands
Unknown Facility
Enschede, Netherlands
Unknown Facility
Geldrop, Netherlands
Unknown Facility
Heerde, Netherlands
Unknown Facility
Heerenveen, Netherlands
Unknown Facility
Hoorn, Netherlands
Unknown Facility
Kampen, Netherlands
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Purmerend, Netherlands
Unknown Facility
Roermond, Netherlands
Unknown Facility
Vlaardingen, Netherlands
Unknown Facility
Zwolle, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag B.V. Clinical Trial
Janssen-Cilag B.V.
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2008
First Posted
June 16, 2008
Study Start
March 1, 2008
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 28, 2014
Record last verified: 2014-04