Clinical trial NCT00696813: Observational Study to Assess Outcomes During Antipsychotic Treatment With Paliperidone ER or Other Oral Antipsychotics
Official title: PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Registry
Healthcare Utilization
Outcome
Safety
Efficacy
Cost-effectiveness
Paliperidone ER
Invega®
Oral antipsychotics
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 3064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of medical health professionals with a diagnosis of schizophrenia

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary treatment duration and time to treatment discontinuation
timeFrame: Prospective 1-year observation period
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: Use of concomitant medications
timeFrame: during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation
measure: Deterioration of the psychotic condition
timeFrame: at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation
Other outcomes:
Locations:
city: Victoria
country: Canada
state: British Columbia
city: Burlington
country: Canada
state: Ontario
city: Chatham
country: Canada
state: Ontario
city: Kingston
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Halifax N/A
country: Canada
city: London
country: Canada
city: Windsor
country: Canada
city: Boskovice
country: Czech Republic
city: Brno - Lesná
country: Czech Republic
city: Brno - Židenice
country: Czech Republic
city: Brno
country: Czech Republic
city: Děčín 1
country: Czech Republic
city: Frýdek Místek
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Hradec Králové
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Kolín
country: Czech Republic
city: Kutná Hora
country: Czech Republic
city: Litomyšl
country: Czech Republic
city: Litoměřice
country: Czech Republic
city: Lnáře
country: Czech Republic
city: Mladá Boleslav
country: Czech Republic
city: Nový Jičín
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava-Poruba
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Pardubice
country: Czech Republic
city: Plzeň
country: Czech Republic
city: Prague
country: Czech Republic
city: Praha 8
country: Czech Republic
city: Praha 9
country: Czech Republic
city: Prerov
country: Czech Republic
city: Písek
country: Czech Republic
city: Roudnice
country: Czech Republic
city: Teplice
country: Czech Republic
city: Třebíč
country: Czech Republic
city: Vyškov
country: Czech Republic
city: Zábřeh
country: Czech Republic
city: Ústí Nad Labem
country: Czech Republic
city: České Budějovice
country: Czech Republic
city: Český Krumlov
country: Czech Republic
city: Šternberk
country: Czech Republic
city: Aarhus C
country: Denmark
city: Augustenborg N/A
country: Denmark
city: Frederiksberg
country: Denmark
city: Gentofte
country: Denmark
city: København
country: Denmark
city: Middelfart N/A
country: Denmark
city: Odense C
country: Denmark
city: Toender
country: Denmark
city: Almaty
country: Kazakhstan
city: Astana
country: Kazakhstan
city: Petropavlovsc
country: Kazakhstan
city: Shymkent
country: Kazakhstan
city: Taldykorgan
country: Kazakhstan
city: Borås
country: Sweden
city: Bromma
country: Sweden
city: Falköping
country: Sweden
city: Falun
country: Sweden
city: Göteborg
country: Sweden
city: Härnösand
country: Sweden
city: Jönköping
country: Sweden
city: Ljungby
country: Sweden
city: Malmö N/A
country: Sweden
city: Mölndal
country: Sweden
city: Norrköping
country: Sweden
city: Sundsvall N/A
country: Sweden
city: Tyresö
country: Sweden
city: Uddevalla
country: Sweden
city: Varberg
country: Sweden
city: Västra Frölunda
country: Sweden
city: Khon Kaen
country: Thailand
city: Songkhla
country: Thailand
city: Beregovo
country: Ukraine
city: Donetsk
country: Ukraine
city: Glevakha
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Krivoy Rog
country: Ukraine
city: Simferopol
country: Ukraine
city: Smela
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsa
country: Ukraine
Study officials:
affiliation: Janssen Pharmaceutica N.V.
name: Janssen Pharmaceutica N.V. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.