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

Overview

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.

Full Title of Study: “Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: December 2014

Detailed Description

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

Arms, Groups and Cohorts

• 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].

Clinical Trial Outcome Measures

Primary Measures

• Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
  • Time Frame: 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.
  • Time Frame: At inclusion
  • Age, gender, educational and professional status, co-habitation are going to be described.
• Descriptive analysis of medical history.
  • Time Frame: 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).
  • Time Frame: 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 Measures

• Change in Clinical Global Impressions Scale – Severity (CGI-S) during the treatment.
  • Time Frame: 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.
  • Time Frame: From baseline to 12 months
• Descriptive analysis of the treatment changes: drug switches.
  • Time Frame: From baseline to 12 months
• Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.
  • Time Frame: From baseline to 12 months
• Change in Body Mass Index (BMI).
  • Time Frame: From baseline to 12 months
• Laboratory tests- cholesterol.
  • Time Frame: From baseline to 12 months
  • Blood test- cholesterol.
• Descriptive analysis of all adverse events.
  • Time Frame: From baseline to 12 months
• Relapses (only for the schizophrenia subpopulation).
  • Time Frame: 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.
  • Time Frame: From baseline to 12 months
  • Blood test- glycemia.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 130 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • AstraZeneca
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Bruno FALISSARD, Pr, Principal Investigator, Paris
  • Pierre-Michel LLORCA, Pr, Principal Investigator, Clermont-Ferrand