Observational Study to Assess Outcomes During Antipsychotic Treatment With Paliperidone ER or Other Oral Antipsychotics
PILAR
PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry
2 other identifiers
observational
3,064
7 countries
84
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Typical duration for all trials
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 5, 2008
CompletedFirst Posted
Study publicly available on registry
June 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFebruary 5, 2013
February 1, 2013
2.6 years
June 5, 2008
February 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Deterioration of the psychotic condition
at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation
Study Arms (2)
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
Eligibility Criteria
Patients of medical health professionals with a diagnosis of schizophrenia
You may qualify if:
- 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
You may not qualify if:
- Established treatment-refractory schizophrenia
- History of neuroleptic malignant syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
Unknown Facility
Victoria, British Columbia, Canada
Unknown Facility
Burlington, Ontario, Canada
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Chatham, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Halifax, Canada
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London, Canada
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Windsor, Canada
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Boskovice, Czechia
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Brno, Czechia
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Brno - Lesná, Czechia
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Brno-Židenice, Czechia
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České Budějovice, Czechia
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Český Krumlov, Czechia
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Děčín, Czechia
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Frýdek-Místek, Czechia
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Hradec Králové, Czechia
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Jindřichův Hradec, Czechia
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Kolín, Czechia
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Kutná Hora, Czechia
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Litoměřice, Czechia
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Litomyšl, Czechia
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Lnáře, Czechia
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Mladá Boleslav, Czechia
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Nový Jičín, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Ostrava-Poruba, Czechia
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Pardubice, Czechia
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Pilsen, Czechia
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Písek, Czechia
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Prague, Czechia
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Přerov, Czechia
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Roudnice, Czechia
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Sternberk, Czechia
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Teplice, Czechia
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Třebíč, Czechia
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Ústí nad Labem, Czechia
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Vyškov, Czechia
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Zábřeh, Czechia
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Aarhus C, Denmark
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Augustenborg, Denmark
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Copenhagen, Denmark
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Frederiksberg, Denmark
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Gentofte Municipality, Denmark
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Middelfart, Denmark
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Odense C, Denmark
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Toender, Denmark
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Almaty, Kazakhstan
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Astana, Kazakhstan
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Petropavlovsc, Kazakhstan
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Shymkent, Kazakhstan
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Taldykorgan, Kazakhstan
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Borås, Sweden
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Bromma, Sweden
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Falköping, Sweden
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Falun, Sweden
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Gothenburg, Sweden
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Härnösand, Sweden
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Jönköping, Sweden
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Ljungby, Sweden
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Malmo, Sweden
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Mölndal, Sweden
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Norrköping, Sweden
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Sundsvall, Sweden
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Tyresö, Sweden
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Uddevalla, Sweden
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Varberg, Sweden
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Västra Frölunda, Sweden
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Khon Kaen, Thailand
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Songkhla, Thailand
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Berehove, Ukraine
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Donetsk, Ukraine
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Hlevakha, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Kryvyi Rih, Ukraine
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Simferopol, Ukraine
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Smila, Ukraine
Unknown Facility
Uzhhorod, Ukraine
Unknown Facility
Vinnitsa, Ukraine
Related Publications (1)
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.
PMID: 24597755DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 5, 2008
First Posted
June 13, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 5, 2013
Record last verified: 2013-02