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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00696813
• Lead Sponsor: Janssen-Cilag International NV

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.

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 Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-13
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3064

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary treatment duration and time to treatment discontinuation	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

Name	Time	Method
Deterioration of the psychotic condition	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
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.	12 months
Use of concomitant medications	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