Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study

December 14, 2015 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

Description of the use of Quetiapine Extended Release (XR) in real-life practice in France

Study Type

Observational

Enrollment (Actual)

2292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil Cedex, France
        • Research Site
      • Belley, France
        • Research Site
      • Castelmaurou, France
        • Research Site
      • Cavaillon, France
        • Reserach Site
      • Les Mureaux, France
        • Research Site
      • Lille, France
        • Research Site
      • Marseille, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Nimes Cedex, France
        • Research Site
      • Obernai, France
        • Research Site
      • Paris, France
        • Research Site
      • Rennes, France
        • Research Site
      • Saintes Cedex, France
        • Research Site
      • Sens, France
        • Research Site
      • St Dizier, France
        • Research Site
      • St Egreve Cedex, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Tours, France
        • Research Site
      • Ussel Cedex, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospital, clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
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).
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].

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
Time Frame: At inclusion
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.
At inclusion
Description of patient's socio-demographics profile.
Time Frame: At inclusion
Age, gender, educational and professional status, co-habitation are going to be described.
At inclusion
Descriptive analysis of medical history.
Time Frame: At inclusion
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.
At inclusion
Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).
Time Frame: At inclusion

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.
Time Frame: From baseline to 12 months

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
Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.
Time Frame: From baseline to 12 months
From baseline to 12 months
Descriptive analysis of the treatment changes: drug switches.
Time Frame: From baseline to 12 months
From baseline to 12 months
Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.
Time Frame: From baseline to 12 months
From baseline to 12 months
Change in Body Mass Index (BMI).
Time Frame: From baseline to 12 months
From baseline to 12 months
Laboratory tests- cholesterol.
Time Frame: From baseline to 12 months
Blood test- cholesterol.
From baseline to 12 months
Descriptive analysis of all adverse events.
Time Frame: From baseline to 12 months
From baseline to 12 months
Relapses (only for the schizophrenia subpopulation).
Time Frame: From baseline to 12 months
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.
From baseline to 12 months
Laboratory tests- glycemia.
Time Frame: From baseline to 12 months
Blood test- glycemia.
From baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Bruno FALISSARD, Pr, Paris
  • Principal Investigator: Pierre-Michel LLORCA, Pr, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 18, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NFR-SER-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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