Bipolar Episodes, Schizophrenia
Conditions
Keywords
Schizophrenia, Bipolar episodes, France, Xeroquel, Real-life
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
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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. |
| 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. |
| 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. |
Countries
France
Outcome results
None listed