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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: INVega Is Studied In an Observational Design in the Netherlands

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: March 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Drug: Paliperidone ER
6 mg tablet once daily, variable treatment length.

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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697658

Locations
Netherlands
Alphen Aan Den Rijn, Netherlands
Amersfoort, Netherlands
Amsterdam, Netherlands
Beverwijk, Netherlands
Deventer, Netherlands
Echt, Netherlands
Enschede, Netherlands
Geldrop, Netherlands
Heerde, Netherlands
Heerenveen, Netherlands
Hoorn Nh, Netherlands
Kampen, Netherlands
Nijmegen, Netherlands
Purmerend, Netherlands
Roermond, Netherlands
Vlaardingen, Netherlands
Zwolle, Netherlands
Sponsors and Collaborators
Janssen-Cilag B.V.
Investigators
Study Director: Janssen-Cilag B.V. Clinical Trial Janssen-Cilag B.V.
  More Information

No publications provided

Responsible Party: Janssen-Cilag B.V.
ClinicalTrials.gov Identifier: NCT00697658     History of Changes
Other Study ID Numbers: CR014788, R076477SCH4017
Study First Received: April 11, 2008
Last Updated: April 24, 2014
Health Authority: Netherlands: Netherlands Medicines Evaluation Board

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 23, 2014