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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag B.V.
ClinicalTrials.gov Identifier:
NCT00697658
First received: April 11, 2008
Last updated: April 24, 2014
Last verified: April 2014

April 11, 2008
April 24, 2014
March 2008
November 2009   (final data collection date for primary outcome measure)
Change from baseline in CGI-S score at the end of the study [ Time Frame: Week 26 or drop out visit ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00697658 on ClinicalTrials.gov Archive Site
  • Change in Health of the Nation Outcome Scales (HoNOS) [ Time Frame: Week 26 or drop out visit ] [ Designated as safety issue: No ]
  • Change in GAF score [ Time Frame: Week 26 or drop out visit ] [ Designated as safety issue: No ]
  • Patient satisfaction with treatment [ Time Frame: Week 26 or drop out visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Schizophrenia
Drug: Paliperidone ER
6 mg tablet once daily, variable treatment length.
001
Intervention: Drug: Paliperidone ER
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00697658
CR014788, R076477SCH4017
No
Janssen-Cilag B.V.
Janssen-Cilag B.V.
Not Provided
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
Janssen-Cilag B.V.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP