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

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Janssen

Status

Completed

Conditions

Schizophrenia

Study type

Observational

Funder types

Industry

Identifiers

NCT00696813
R076477SCH4016 (Other Identifier)
CR014707

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,064 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

3,064 participants in 2 patient groups

paliperidone ER
Description:
Newly switched to or started on Paliperidone ER, not longer than 2 weeks ago
Any other oral antipsychotic
Description:
Newly switched to or started on any other oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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