SchizophreniaNCT01689389
Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study
An observational study of Schizophrenia and Bipolar Episodes, run by AstraZeneca at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Schizophrenia, Bipolar Episodes
- Type of treatment
- Injection or infusion
- How many people
- 2,292 participants
- Where
- 19 sitesFrance
- Study dates
- Dec 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital, clinic
Who may be able to join
- New patients treated with Xeroquel XR
- Patients aged 18 years and over
- Diagnosis of bipolar disorder or schizophrenia according to DSM-IV criteria
Who cannot join
- Patient included in a therapeutic trial (Huriet-Serusclat Act)
- Patient refusing to participate in the study
- Pregnant women
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Research Site
Argenteuil
Research Site
Belley
Research Site
Castelmaurou
Reserach Site
Cavaillon
Research Site
Les Mureaux
Research Site
Lille
Research Site
Marseille
Research Site
Montpellier
Research Site
Nîmes
Research SIte
Obernai
Research Site
Paris
Research Site
Rennes
research Site
Saint-Dizier
Research Site
Saint-Égrève
Research Site
Saintes
Research Site
Sens
Research Site
Toulouse
Research Site
Tours
Research Site
Ussel
About this study
Official 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.
Read the detailed description
Description of the use of Quetiapine Extended Release (XR) in real-life practice in France
- Conditions
- Schizophrenia, Bipolar Episodes
- Keywords
- Schizophrenia, Bipolar episodes, France, Xeroquel, Real-life
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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]. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion
Description of patient's socio-demographics profile.
Age, gender, educational and professional status, co-habitation are going to be described.
Measured: At inclusion
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.
Measured: 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.
Measured: At inclusion
Secondary outcomes (9)
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.
Measured: From baseline to 12 months
Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.
Measured: From baseline to 12 months
Descriptive analysis of the treatment changes: drug switches.
Measured: From baseline to 12 months
Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.
Measured: From baseline to 12 months
Change in Body Mass Index (BMI).
Measured: From baseline to 12 months
Laboratory tests- cholesterol.
Blood test- cholesterol.
Measured: From baseline to 12 months
Descriptive analysis of all adverse events.
Measured: 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.
Measured: From baseline to 12 months
Laboratory tests- glycemia.
Blood test- glycemia.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruno FALISSARD, Pr, Principal investigator, ParisPierre-Michel LLORCA, Pr, Principal investigator, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689389
- Sponsor's protocol ID
- NIS-NFR-SER-2012/1
- Status last verified
- Dec 2015
- First submitted
- 18 Sep 2012
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France
- ClinicalTrials.gov ID
- NCT01689389
- Acronym / sponsor ID
- NIS-NFR-SER-2012/1
- Conditions
- Schizophrenia, Bipolar Episodes
- Keywords
- Schizophrenia, Bipolar episodes, France, Xeroquel, Real-life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,292 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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]. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital, clinic
Key inclusion criteria (3 listed)
- New patients treated with Xeroquel XR
- Patients aged 18 years and over
- Diagnosis of bipolar disorder or schizophrenia according to DSM-IV criteria
Key exclusion criteria (3 listed)
- Patient included in a therapeutic trial (Huriet-Serusclat Act)
- Patient refusing to participate in the study
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.
Time frame: From baseline to 12 months
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
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
Laboratory tests- glycemia.
Time frame: From baseline to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
- NIS-NFR-SER-2012/1 SUMMARY SYNOPSISLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno FALISSARD, Pr principal investigator
Paris
Pierre-Michel LLORCA, Pr principal investigator
Clermont-Ferrand
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Episodes, run by AstraZeneca at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive analysis of variables related with how the drug is prescribed and used by the patient. (time frame: At inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.