Observational Study to Assess Outcomes During Antipsychotic Treatment With Paliperidone ER or Other Oral Antipsychotics (PILAR)

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00696813
First received: June 5, 2008
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

The purpose of this non-interventional, observational and international registry study is to document the prescribing patterns in daily clinical practice and to assess long term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting.


Condition Phase
Schizophrenia
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • Primary treatment duration and time to treatment discontinuation [ Time Frame: Prospective 1-year observation period ] [ Designated as safety issue: No ]
    Primary treatment duration is defined as the time interval (in days) between baseline and stop of the new antipsychotic treatment started at baseline.


Secondary Outcome Measures:
  • The prospectively documented treatment outcomes also include overall severity of symptoms, personal and social performance, healthcare utilization and health related quality of life and quality of sleep. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Use of concomitant medications [ Time Frame: during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation ] [ Designated as safety issue: No ]
    Use (Yes/No) of each class of concomitant medications

  • Deterioration of the psychotic condition [ Time Frame: at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation ] [ Designated as safety issue: No ]
    A significant deterioration of the psychotic condition is defined as 1 of the following: (a) full hospitalization for exacerbation of psychotic symptoms, (b) need for an increase in level of care, antipsychotic dose increase other than for titration, change in concomitant medication to treat the psychotic symptoms combined with a worsening of psychotic symptoms equivalent to an increase in CGI-S by at least 2 points, (c) deliberate self-injury, (d) emergence of suicidal or homicidal ideation, (e) violent behavior resulting in significant injury to another person or significant property damage


Enrollment: 3064
Study Start Date: June 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
paliperidone ER
Newly switched to or started on Paliperidone ER, not longer than 2 weeks ago
Any other oral antipsychotic
Newly switched to or started on any other oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago

Detailed Description:

PILAR is a non-interventional, observational, international registry on the use of oral antipsychotics in a naturalistic setting in patients with schizophrenia. Patients initiating a new oral antipsychotic treatment are candidates for documentation in this registry. All patients should be treated according to local labeling specifications. The overall study objective is to document prescribing patterns in daily clinical practice and to assess long-term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting. The primary objective is to prospectively document over one year treatment outcomes and healthcare utilization data that will enable a cost-effectiveness analysis of paliperidone ER compared to other oral antipsychotic treatments. Additional objectives are to retrospectively collect data over one year, which will allow the evaluation of treatment outcomes before and after treatment initiation with paliperidone ER or other oral antipsychotics. Evaluation of Adverse Drug Reactions (ADR) and Serious Adverse Drug Reactions (SADR) for the retrospective period, and Adverse Events (AE) and Serious Adverse Events (SAE) during the prospective period will be performed and reported. Dosing and administration of all treatments should be prescribed at the physician's discretion, and should be based on approved local labels. Dose adjustments or medication changes should be made by the treating physician based on clinical judgment and usual practice. Subjects should receive their medication according to usual care in their treatment setting, and no study drug will be provided. The documentation of the treatment will last one year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients of medical health professionals with a diagnosis of schizophrenia

Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia
  • Switch to or start on paliperidone ER or another oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago
  • Signed informed consent is available at the beginning of documentation
  • Able and willing to fill-out self-administered questionnaires

Exclusion Criteria:

  • Established treatment-refractory schizophrenia
  • History of neuroleptic malignant syndrome
  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: NCT00696813

  Show 88 Study Locations
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.
  More Information

Additional Information:
No publications provided by Janssen-Cilag International NV

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMEA Therapeutic Area Leader CNS, Janssen-Cilag Germany
ClinicalTrials.gov Identifier: NCT00696813     History of Changes
Obsolete Identifiers: NCT01615133
Other Study ID Numbers: CR014707, R076477SCH4016
Study First Received: June 5, 2008
Last Updated: February 4, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen-Cilag International NV:
Registry
Healthcare Utilization
Outcome
Safety
Efficacy
Cost-effectiveness
Paliperidone ER
Invega®
Oral antipsychotics

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
9-hydroxy-risperidone
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 August 27, 2014