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

NCT ID: NCT00696813

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3064 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-01-31

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.

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

paliperidone ER

Newly switched to or started on Paliperidone ER, not longer than 2 weeks ago

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Janssen-Cilag Germany

Principal Investigators

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Locations

Victoria, British Columbia, Canada

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

Malmo, , 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

Countries

Canada; Czechia; Denmark; Kazakhstan; Sweden; Thailand; Ukraine

References

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.

Reference Type: DERIVED

PMID: 24597755 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=397&filename=CR014707_CSR.pdf

Pharmacoepidemiologic International Longitudinal Antipsychotic Registry PILAR

Other Identifiers

R076477SCH4016

Identifier Type: OTHER

Identifier Source: secondary_id

CR014707

Identifier Type: -

Identifier Source: org_study_id

NCT01615133

Identifier Type: -

Identifier Source: nct_alias