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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone ER

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001	Drug: Paliperidone ER; 6 mg tablet once daily, variable treatment length.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in CGI-S score at the end of the study	Week 26 or drop out visit

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen-Cilag B.V.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: April 11, 2008
• First Submitted That Met QC Criteria: June 13, 2008
• First Posted (ESTIMATE): June 16, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 28, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Paliperidone ER
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: CR014788; R076477SCH4017