Schizophrenia Clinical Trial
— TBDOfficial title:
Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
France,
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 |
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