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Completed

NCT Number: NCT01689389

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

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.

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Key information

Conditions

Schizophrenia Bipolar Episodes Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Argenteuil, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. Description of patient's socio-demographics profile.

    Time frame: At inclusion

    Age, gender, educational and professional status, co-habitation are going to be described.

  3. 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.

  4. 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 outcomes

  1. 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.

  2. Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.

    Time frame: From baseline to 12 months

  3. Descriptive analysis of the treatment changes: drug switches.

    Time frame: From baseline to 12 months

  4. Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.

    Time frame: From baseline to 12 months

  5. Change in Body Mass Index (BMI).

    Time frame: From baseline to 12 months

  6. Laboratory tests- cholesterol.

    Time frame: From baseline to 12 months

    Blood test- cholesterol.

  7. Descriptive analysis of all adverse events.

    Time frame: From baseline to 12 months

  8. 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.

  9. Laboratory tests- glycemia.

    Time frame: From baseline to 12 months

    Blood test- glycemia.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 21, 2012
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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