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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01689389

Collaborator

(none)

2,292

Enrollment

Locations

Duration (Months)

120.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Bipolar Episodes

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

2292 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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].

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 130 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Argenteuil Cedex	France
2	Research Site	Belley	France
3	Research Site	Castelmaurou	France
4	Reserach Site	Cavaillon	France
5	Research Site	Les Mureaux	France
6	Research Site	Lille	France
7	Research Site	Marseille	France
8	Research Site	Montpellier	France
9	Research Site	Nimes Cedex	France
10	Research SIte	Obernai	France
11	Research Site	Paris	France
12	Research Site	Rennes	France
13	Research Site	Saintes Cedex	France
14	Research Site	Sens	France
15	research Site	St Dizier	France
16	Research Site	St Egreve Cedex	France
17	Research Site	Toulouse	France
18	Research Site	Tours	France
19	Research Site	Ussel Cedex	France