Clinical trial NCT01689389: Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study
Official title: Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Episodes
Keywords: Schizophrenia
Bipolar episodes
France
Xeroquel
Real-life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 2292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital, clinic

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
timeFrame: At inclusion
measure: Description of patient's socio-demographics profile.
timeFrame: At inclusion
measure: Descriptive analysis of medical history.
timeFrame: At inclusion
measure: Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).
timeFrame: At inclusion
Secondary outcomes:
measure: Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.
timeFrame: From baseline to 12 months
measure: Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.
timeFrame: From baseline to 12 months
measure: Descriptive analysis of the treatment changes: drug switches.
timeFrame: From baseline to 12 months
measure: Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.
timeFrame: From baseline to 12 months
measure: Change in Body Mass Index (BMI).
timeFrame: From baseline to 12 months
measure: Laboratory tests- cholesterol.
timeFrame: From baseline to 12 months
measure: Descriptive analysis of all adverse events.
timeFrame: From baseline to 12 months
measure: Relapses (only for the schizophrenia subpopulation).
timeFrame: From baseline to 12 months
measure: Laboratory tests- glycemia.
timeFrame: From baseline to 12 months
Other outcomes:
Locations:
city: Argenteuil Cedex
country: France
facility: Research Site
city: Belley
country: France
facility: Research Site
city: Castelmaurou
country: France
facility: Research Site
city: Cavaillon
country: France
facility: Reserach Site
city: Les Mureaux
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nimes Cedex
country: France
facility: Research Site
city: Obernai
country: France
facility: Research SIte
city: Paris
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Saintes Cedex
country: France
facility: Research Site
city: Sens
country: France
facility: Research Site
city: St Dizier
country: France
facility: research Site
city: St Egreve Cedex
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Ussel Cedex
country: France
facility: Research Site
Study officials:
affiliation: Paris
name: Bruno FALISSARD, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Clermont-Ferrand
name: Pierre-Michel LLORCA, Pr
role: PRINCIPAL_INVESTIGATOR
References: