NCT00696813

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

PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,064 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Schizophrenia

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-06-13
• Last updated: 2013-02-05

Locations

84 sites across 7 countries: Canada, Czechia, Denmark, Kazakhstan, Sweden, Thailand, Ukraine