Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH4016 | Other Identifier | Janssen-Cilag International NV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients of medical health professionals with a diagnosis of schizophrenia
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V. Clinical Trial | Janssen Pharmaceutica N.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria | British Columbia | Canada | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24597755 | Derived | Schreiner A, Hargarter L, Hitschfield K, Lee JI, Lenskaya I, Sulaiman AH, Diels J; PILAR study group. Clinical effectiveness and resource utilization of paliperidone ER for schizophrenia: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry (PILAR). Curr Med Res Opin. 2014 Jul;30(7):1279-89. doi: 10.1185/03007995.2014.898630. Epub 2014 Mar 19. |
| Label | URL |
|---|---|
| Pharmacoepidemiologic International Longitudinal Antipsychotic Registry PILAR | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Burlington |
| Ontario |
| Canada |
| Chatham | Ontario | Canada |
| Greater Sudbury | Ontario | Canada |
| Kingston | Ontario | Canada |
| London | Ontario | Canada |
| Montreal | Quebec | Canada |
| Halifax | Canada |
| London | Canada |
| Windsor | Canada |
| Boskovice | Czechia |
| Brno | Czechia |
| Brno - Lesná | Czechia |
| Brno-Židenice | Czechia |
| České Budějovice | Czechia |
| Český Krumlov | Czechia |
| Děčín | Czechia |
| Frýdek-Místek | Czechia |
| Hradec Králové | Czechia |
| Jindřichův Hradec | Czechia |
| Kolín | Czechia |
| Kutná Hora | Czechia |
| Litoměřice | Czechia |
| Litomyšl | Czechia |
| Lnáře | Czechia |
| Mladá Boleslav | Czechia |
| Nový Jičín | Czechia |
| Olomouc | Czechia |
| Ostrava | Czechia |
| Ostrava-Poruba | Czechia |
| Pardubice | Czechia |
| Pilsen | Czechia |
| Písek | Czechia |
| Prague | Czechia |
| Přerov | Czechia |
| Roudnice | Czechia |
| Sternberk | Czechia |
| Teplice | Czechia |
| Třebíč | Czechia |
| Ústí nad Labem | Czechia |
| Vyškov | Czechia |
| Zábřeh | Czechia |
| Aarhus C | Denmark |
| Augustenborg | Denmark |
| Copenhagen | Denmark |
| Frederiksberg | Denmark |
| Gentofte Municipality | Denmark |
| Middelfart | Denmark |
| Odense C | Denmark |
| Toender | Denmark |
| Almaty | Kazakhstan |
| Astana | Kazakhstan |
| Petropavlovsc | Kazakhstan |
| Shymkent | Kazakhstan |
| Taldykorgan | Kazakhstan |
| Borås | Sweden |
| Bromma | Sweden |
| Falköping | Sweden |
| Falun | Sweden |
| Gothenburg | Sweden |
| Härnösand | Sweden |
| Jönköping | Sweden |
| Ljungby | Sweden |
| Malmö | Sweden |
| Mölndal | Sweden |
| Norrköping | Sweden |
| Sundsvall | Sweden |
| Tyresö | Sweden |
| Uddevalla | Sweden |
| Varberg | Sweden |
| Västra Frölunda | Sweden |
| Khon Kaen | Thailand |
| Songkhla | Thailand |
| Berehove | Ukraine |
| Donetsk | Ukraine |
| Hlevakha | Ukraine |
| Ivano-Frankivsk | Ukraine |
| Kharkiv | Ukraine |
| Kiev | Ukraine |
| Kryvyi Rih | Ukraine |
| Simferopol | Ukraine |
| Smila | Ukraine |
| Uzhhorod | Ukraine |
| Vinnitsa | Ukraine |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided