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.
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
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
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
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
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
Kazakhstan5 sites
Study site
Almaty
Study site
Astana
Study site
Petropavlovsc
Study site
Shymkent
Study site
Taldykorgan
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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry
- ClinicalTrials.gov ID
- NCT00696813
- Acronym / sponsor ID
- PILAR / CR014707
- Conditions
- Schizophrenia
- Keywords
- Registry, Healthcare Utilization, Outcome, Safety, Efficacy, Cost-effectiveness, Paliperidone ER, Invega®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,064 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of medical health professionals with a diagnosis of schizophrenia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Established treatment-refractory schizophrenia
- History of neuroleptic malignant syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary treatment duration and time to treatment discontinuation
Time frame: Prospective 1-year observation period
Primary treatment duration is defined as the time interval (in days) between baseline and stop of the new antipsychotic treatment started at baseline.
3 secondary outcomes
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.
Time frame: 12 months
Use of concomitant medications
Time frame: 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
Time frame: at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Derived from this study: PubMed 24597755Schreiner 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.
- Pharmacoepidemiologic International Longitudinal Antipsychotic Registry PILARLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
84 sites in 7 countries: see every site and its status.
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.