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

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

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

Conditions
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Schizophrenia, Bipolar Episodes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main study population<br>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<br>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<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Description of patient's socio-demographics profile. | Age, gender, educational and professional status, co-habitation are going to be described. | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | Blood test- cholesterol. | From baseline to 12 months | 
| Descriptive analysis of all adverse events. |  | From baseline to 12 months | 
| 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 | 
| Laboratory tests- glycemia. | Blood test- glycemia. | From baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Bipolar episodes, France, Xeroquel, Real-life