We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00696813
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : February 5, 2013
Information provided by:

Study Description
Brief Summary:
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 or disease Phase
Schizophrenia Phase 4

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.

Study Design

Study Type : Observational
Actual Enrollment : 3064 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry
Study Start Date : June 2008
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and 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

Outcome Measures

Primary Outcome Measures :
  1. Primary treatment duration and time to treatment discontinuation [ Time Frame: Prospective 1-year observation period ]
    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 :
  1. 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 ]
  2. 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 ]
    Use (Yes/No) of each class of concomitant medications

  3. Deterioration of the psychotic condition [ Time Frame: at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of medical health professionals with a diagnosis of schizophrenia

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696813

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

Additional Information:
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 ( Other Identifier: Janssen-Cilag International NV )
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by Janssen-Cilag International NV:
Healthcare Utilization
Paliperidone ER
Oral antipsychotics

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Paliperidone Palmitate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents