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INVISION - An Observational Study to Explore Effecitivenss, Tolerability and Safety of Paliperidone ER in Patients With Schizoprenia.
This study is currently recruiting participants.
Verified by Janssen-Cilag B.V., December 2008
Sponsored by: Janssen-Cilag B.V.
Information provided by: Janssen-Cilag B.V.
ClinicalTrials.gov Identifier: NCT00697658
  Purpose

The purpose of this study is to explore efficacy, tolerability and safety of paliperidone ER in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.


Condition Phase
Schizophrenia
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Paliperidone
U.S. FDA Resources
Study Type: Observational
Official Title: INVega Is Studied In an Observational Design in the Netherlands.

Further study details as provided by Janssen-Cilag B.V.:

Estimated Enrollment: 250
Study Start Date: February 2008
Detailed Description:

This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone ER in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in 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;To explore possible association between CGI-S, GAF and HoNOS.

The patients will receive paliperidone ER (6 mg, 9 mg or other dosages within 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 SmPC.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject 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, subject satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available
  • Subject 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697658

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

Locations
Netherlands
Recruiting
Beverwijk, Netherlands
Recruiting
Purmerend, Netherlands
Recruiting
Zaandam, Netherlands, 1502 DV
Recruiting
Amstelveen, Netherlands
Recruiting
Alphen Aan Den Rijn, Netherlands
Recruiting
Amsterdam, Netherlands
Recruiting
Terneuzen, Netherlands, 4531GL
Recruiting
Kloetinge, Netherlands, 4481PM
Recruiting
Geldrop, Netherlands, 5664 EH
Recruiting
Echt, Netherlands
Recruiting
Tilburg, Netherlands, 5042 AD
Recruiting
Deventer, Netherlands
Recruiting
Amersfoort, Netherlands, 3816 CP
Recruiting
Blaricum, Netherlands, 1261 AN
Recruiting
Ede Gld, Netherlands, 6716 RR
Recruiting
Vlaardingen, Netherlands
Recruiting
Doetinchem, Netherlands
Recruiting
Roermond, Netherlands, 6042BL
Recruiting
Kampen, Netherlands
Recruiting
Hoorn Nh, Netherlands
Recruiting
Groningen, Netherlands
Recruiting
Heerenveen, Netherlands, 8441NC
Recruiting
Venray, Netherlands, 5803 AC
Recruiting
Heerde, Netherlands
Sponsors and Collaborators
Janssen-Cilag B.V.
Investigators
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Study ID Numbers: CR014788
Study First Received: April 11, 2008
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00697658  
Health Authority: Netherlands: Netherlands Medicines Evaluation Board

Keywords provided by Janssen-Cilag B.V.:
paliperidone ER
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Risperidone
9-hydroxy-risperidone
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009