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

Study Overview
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Brief Summary
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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
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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.

Official Title
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PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry

Conditions
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Schizophrenia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| paliperidone ER<br>Newly switched to or started on Paliperidone ER, not longer than 2 weeks ago | |
| Any other oral antipsychotic<br>Newly switched to or started on any other oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary treatment duration and time to treatment discontinuation | Primary treatment duration is defined as the time interval (in days) between baseline and stop of the new antipsychotic treatment started at baseline. | Prospective 1-year observation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Use (Yes/No) of each class of concomitant medications | during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation | 
| Deterioration of the psychotic condition | 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 | at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Healthcare Utilization, Outcome, Safety, Efficacy, Cost-effectiveness, Paliperidone ER, Invega®, Oral antipsychotics