Clinical trial NCT00697658: INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
Official title: INVega Is Studied In an Observational Design in the Netherlands
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Paliperidone ER
Schizophrenia
Lead sponsor: Janssen-Cilag B.V.
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in CGI-S score at the end of the study
timeFrame: Week 26 or drop out visit
Secondary outcomes:
measure: Change in Health of the Nation Outcome Scales (HoNOS)
timeFrame: Week 26 or drop out visit
measure: Change in GAF score
timeFrame: Week 26 or drop out visit
measure: Patient satisfaction with treatment
timeFrame: Week 26 or drop out visit
Other outcomes:
Locations:
city: Alphen Aan Den Rijn
country: Netherlands
city: Amersfoort
country: Netherlands
city: Amsterdam
country: Netherlands
city: Beverwijk
country: Netherlands
city: Deventer
country: Netherlands
city: Echt
country: Netherlands
city: Enschede
country: Netherlands
city: Geldrop
country: Netherlands
city: Heerde
country: Netherlands
city: Heerenveen
country: Netherlands
city: Hoorn Nh
country: Netherlands
city: Kampen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Purmerend
country: Netherlands
city: Roermond
country: Netherlands
city: Vlaardingen
country: Netherlands
city: Zwolle
country: Netherlands
Study officials:
affiliation: Janssen-Cilag B.V.
name: Janssen-Cilag B.V. Clinical Trial
role: STUDY_DIRECTOR
References: