Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study
14. december 2015 opdateret af: AstraZeneca
Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France
The aim of the study is to describe patient characteristics (demographic and clinical) and the patterns of use of Quetiapine XR in patients receiving the drug for the first time in real-life practice regardless the final diagnosis.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Description of the use of Quetiapine Extended Release (XR) in real-life practice in France
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2292
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Argenteuil Cedex, Frankrig
- Research Site
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Belley, Frankrig
- Research Site
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Castelmaurou, Frankrig
- Research Site
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Cavaillon, Frankrig
- Reserach Site
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Les Mureaux, Frankrig
- Research Site
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Lille, Frankrig
- Research Site
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Marseille, Frankrig
- Research Site
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Montpellier, Frankrig
- Research Site
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Nimes Cedex, Frankrig
- Research Site
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Obernai, Frankrig
- Research Site
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Paris, Frankrig
- Research Site
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Rennes, Frankrig
- Research Site
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Saintes Cedex, Frankrig
- Research Site
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Sens, Frankrig
- Research Site
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St Dizier, Frankrig
- Research Site
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St Egreve Cedex, Frankrig
- Research Site
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Toulouse, Frankrig
- Research Site
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Tours, Frankrig
- Research Site
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Ussel Cedex, Frankrig
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 130 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Hospital, clinic
Beskrivelse
Inclusion Criteria:
- New patients treated with Xeroquel XR
- Patients aged 18 years and over
- Diagnosis of bipolar disorder or schizophrenia according to DSM-IV criteria
Exclusion Criteria:
- Patient included in a therapeutic trial (Huriet-Serusclat Act)
- Patient refusing to participate in the study
- Pregnant women
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Main study population
All eligible patients receiving Quetiapine XR for the first time in the inclusion period regardless the diagnosed disease or the patients' age. Patients aged 18 years and over and diagnosed with bipolar disorder or schizophrenia according to DSM-IV criteria will be followed during 12 months. |
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Schizophrenia SoC sample
Patients would have to be prescribed for the first time with a new (not used during the preceding 3 months) atypical antipsychotic other than Quetiapine XR (irrespective this new atypical antipsychotic is preceded or not by another atypical antipsychotic).
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Bipolar SoC sample
Patients would have to be prescribed a new (not used during the preceding 3 months) antidepressant [N06A], antipsychotic (other than Quetiapine XR) [N05A] or mood stabilizer (including lithium [N05AN], valproate [N03AG01], and lamotrigine [N03AX09].
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
Tidsramme: At inclusion
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Variables related with how the drug is prescribed and used by the patient [doses in mg/day, titration (yes/no), time of administration (morning/middle of the day/afternoon/evening), concomitant treatments] are going to be described.
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At inclusion
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Description of patient's socio-demographics profile.
Tidsramme: At inclusion
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Age, gender, educational and professional status, co-habitation are going to be described.
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At inclusion
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Descriptive analysis of medical history.
Tidsramme: At inclusion
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Diagnosis, family history of psychiatric disorders, number of suicidal attempts within the last 12 months, co-morbidities, treatments received during the last 12 months, laboratory and exam data will be included in the description.
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At inclusion
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Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).
Tidsramme: At inclusion
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The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness. The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. |
At inclusion
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.
Tidsramme: From baseline to 12 months
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The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness. The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients. |
From baseline to 12 months
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Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.
Tidsramme: From baseline to 12 months
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From baseline to 12 months
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Descriptive analysis of the treatment changes: drug switches.
Tidsramme: From baseline to 12 months
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From baseline to 12 months
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Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.
Tidsramme: From baseline to 12 months
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From baseline to 12 months
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Change in Body Mass Index (BMI).
Tidsramme: From baseline to 12 months
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From baseline to 12 months
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Laboratory tests- cholesterol.
Tidsramme: From baseline to 12 months
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Blood test- cholesterol.
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From baseline to 12 months
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Descriptive analysis of all adverse events.
Tidsramme: From baseline to 12 months
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From baseline to 12 months
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Relapses (only for the schizophrenia subpopulation).
Tidsramme: From baseline to 12 months
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New psychiatric hospitalisation, deterioration of the CGI-S (Clinical Global Impressions Scale - Severity) by at least 3 points for a baseline score of 1, at least 2 points for a baseline score of 2 or 3, at least 1 point for a baseline score of 4.
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From baseline to 12 months
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Laboratory tests- glycemia.
Tidsramme: From baseline to 12 months
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Blood test- glycemia.
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From baseline to 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Bruno FALISSARD, Pr, Paris
- Ledende efterforsker: Pierre-Michel LLORCA, Pr, Clermont-Ferrand
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2012
Primær færdiggørelse (Faktiske)
1. december 2014
Studieafslutning (Faktiske)
1. december 2014
Datoer for studieregistrering
Først indsendt
18. september 2012
Først indsendt, der opfyldte QC-kriterier
18. september 2012
Først opslået (Skøn)
21. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIS-NFR-SER-2012/1
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .