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AzTrials

SchizophreniaPILARNCT00696813

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

An observational study of Schizophrenia, run by Janssen-Cilag International NV at 84 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
Type of treatment
Pill or oral medicine
How many people
3,064 participants
Where
84 sitesin 7 countries
Study dates
Jun 2008to Jan 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients of medical health professionals with a diagnosis of schizophrenia

Who may be able to join

  • 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

Who cannot join

  • Established treatment-refractory schizophrenia
  • History of neuroleptic malignant syndrome

Trial locations and contacts

84 sites in 7 countries.

84 sites in 7 countries

Czechia32 sites

  • Study site

    Boskovice

  • Study site

    Brno

  • Study site

    Brno - Lesná

  • Study site

    Brno-Židenice

  • Study site

    České Budějovice

  • Study site

    Český Krumlov

  • Study site

    Děčín

  • Study site

    Frýdek-Místek

  • Study site

    Hradec Králové

  • Study site

    Jindřichův Hradec

  • Study site

    Kolín

  • Study site

    Kutná Hora

  • Study site

    Litoměřice

  • Study site

    Litomyšl

  • Study site

    Lnáře

  • Study site

    Mladá Boleslav

  • Study site

    Nový Jičín

  • Study site

    Olomouc

  • Study site

    Ostrava

  • Study site

    Ostrava-Poruba

  • Study site

    Pardubice

  • Study site

    Pilsen

  • Study site

    Písek

  • Study site

    Prague

  • Study site

    Přerov

  • Study site

    Roudnice

  • Study site

    Sternberk

  • Study site

    Teplice

  • Study site

    Třebíč

  • Study site

    Ústí nad Labem

  • Study site

    Vyškov

  • Study site

    Zábřeh

Other trials in Czechia

Sweden16 sites

  • Study site

    Borås

  • Study site

    Bromma

  • Study site

    Falköping

  • Study site

    Falun

  • Study site

    Gothenburg

  • Study site

    Härnösand

  • Study site

    Jönköping

  • Study site

    Ljungby

  • Study site

    Malmö

  • Study site

    Mölndal

  • Study site

    Norrköping

  • Study site

    Sundsvall

  • Study site

    Tyresö

  • Study site

    Uddevalla

  • Study site

    Varberg

  • Study site

    Västra Frölunda

Other trials in Sweden

Ukraine11 sites

  • Study site

    Berehove

  • Study site

    Donetsk

  • Study site

    Hlevakha

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kryvyi Rih

  • Study site

    Simferopol

  • Study site

    Smila

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

Other trials in Ukraine

Canada10 sites

  • Study site

    Burlington, Ontario

  • Study site

    Chatham, Ontario

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Halifax

  • Study site

    Kingston, Ontario

  • Study site

    London, Ontario

  • Study site

    London

  • Study site

    Montreal, Quebec

  • Study site

    Victoria, British Columbia

  • Study site

    Windsor

Other trials in Canada

Denmark8 sites

  • Study site

    Aarhus C

  • Study site

    Augustenborg

  • Study site

    Copenhagen

  • Study site

    Frederiksberg

  • Study site

    Gentofte Municipality

  • Study site

    Middelfart

  • Study site

    Odense C

  • Study site

    Toender

Other trials in Denmark

Kazakhstan5 sites

  • Study site

    Almaty

  • Study site

    Astana

  • Study site

    Petropavlovsc

  • Study site

    Shymkent

  • Study site

    Taldykorgan

Other trials in Kazakhstan

Thailand2 sites

  • Study site

    Khon Kaen

  • Study site

    Songkhla

Other trials in Thailand

About this study

Official title: PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry

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.

Read the 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
Keywords
Registry, Healthcare Utilization, Outcome, Safety, Efficacy, Cost-effectiveness, Paliperidone ER, Invega®, Oral antipsychotics
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00696813
Study groupRoleWhat they receive
paliperidone ERNewly switched to or started on Paliperidone ER, not longer than 2 weeks ago
Any other oral antipsychoticNewly switched to or started on any other oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Prospective 1-year observation period

Secondary outcomes (3)

  1. 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.

    Measured: 12 months

  2. Use of concomitant medications

    Use (Yes/No) of each class of concomitant medications

    Measured: during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation

  3. 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

    Measured: at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,064 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00696813
Sponsor's protocol ID
CR014707
Other IDs
R076477SCH4016
Acronym
PILAR
Status last verified
Feb 2013
First submitted
5 Jun 2008
Last updated
5 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24597755

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Janssen-Cilag International NV at 84 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Czechia, Sweden, Ukraine, Canada, Denmark and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary treatment duration and time to treatment discontinuation (time frame: Prospective 1-year observation period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00696813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.

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