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

Schizophrenia Clinical Trial

— TBD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689389
• Other study ID #: NIS-NFR-SER-2012/1
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: December 14, 2015
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Transparency Commission of the Haute Autorite de Sante (French National Authority for Health)France: AFSSAPS-ANSM (French Health Products Safety Agency) Risk Management Plan
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2292
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 130 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bipolar Episodes
• Schizophrenia

Locations

Country	Name	City	State
France	Research Site	Argenteuil Cedex
France	Research Site	Belley
France	Research Site	Castelmaurou
France	Reserach Site	Cavaillon
France	Research 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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive analysis of variables related with how the drug is prescribed and used by the patient.	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	No
Primary	Description of patient's socio-demographics profile.	Age, gender, educational and professional status, co-habitation are going to be described.	At inclusion	No
Primary	Descriptive analysis of medical history.	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	No
Primary	Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).	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	No
Secondary	Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.	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	No
Secondary	Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.		From baseline to 12 months	No
Secondary	Descriptive analysis of the treatment changes: drug switches.		From baseline to 12 months	No
Secondary	Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.		From baseline to 12 months	No
Secondary	Change in Body Mass Index (BMI).		From baseline to 12 months	No
Secondary	Laboratory tests- cholesterol.	Blood test- cholesterol.	From baseline to 12 months	No
Secondary	Descriptive analysis of all adverse events.		From baseline to 12 months	Yes
Secondary	Relapses (only for the schizophrenia subpopulation).	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	No
Secondary	Laboratory tests- glycemia.	Blood test- glycemia.	From baseline to 12 months	No

External Links

•   NIS-NFR-SER-2012/1 SUMMARY SYNOPSIS