SchizophreniaNCT01212575
A Retrospective NIS to Evaluate the Use of Seroquel XR and IR in the Clinical Practice of Outpatients With Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 13 sites in Denmark.
Trial summary
The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 186 participants
- Where
- 13 sitesDenmark
- Study dates
- Oct 2010to Feb 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of schizophrenia who are registered at an outpatient district psychiatric clinic
Who may be able to join
- Adults with a diagnosis of schizophrenia from a district psychiatric clinic in Denmark
- Patients who have received at least one dose of Seroquel XR or Seroquel IR during January - March 2010
Who cannot join
- Patients already participating in a clinical study during the study-period.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Denmark13 sites
Research Site
Aabenraa, Aabenraa
Research Site
Aarhus, Arhus
Research Site
Arhus N, Arhus
Research Site
Arhus S, Arhus
Research Site
Ballerup Municipality, Ballerup
Research Site
Cph N, Cph
Research Site
Cph NV, Cph
Research Site
Esbjerg, Esbjerg
Research Site
Haderslev, Haderslev
Research Site
Hillerød, Hillerod
Research Site
Middelfart, Middelfart
Research Site
Rønde, Ronde
Research Site
Tønder, Tonder
About this study
Official title: A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Outpatients With Schizophrenia
The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.
- Conditions
- Schizophrenia
- Keywords
- Mental disorder, Antipsychotic treatment
- Medical subject headings
- Schizophrenia, Mental Disorders
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 |
|---|---|---|
| 300 patients | Female or male aged 18-65 years with a diagnosis of schizophrenia having received at least one dose of Seroquel XR or Seroquel IR during January - March 2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia
Measured: Month 1
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia
Measured: Month 2
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia
Measured: Month 3
Secondary outcomes (9)
Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR
Measured: Month 1
Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR
Measured: Month 2
Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR
Measured: Month 3
Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics
Measured: Month 1
Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics
Measured: Month 2
Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics
Measured: Month 3
The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Measured: Month 1
The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Measured: Month 2
The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Dencker Vansvik, Study director, AstraZeneca Nordic-Södertälje, SwedenCharlotte Emborg, Principal investigator, Skovager 2, Risskov, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212575
- Sponsor's protocol ID
- NIS-NDK-SER-2010/2
- Status last verified
- Mar 2011
- First submitted
- 27 Sep 2010
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Emborg C, Hallerback T, Jorgensen L, Carlborg A. A retrospective study of clinical usage of quetiapine XR and quetiapine IR in outpatients with schizophrenia in Denmark. Hum Psychopharmacol. 2012 Sep;27(5):492-8. doi: 10.1002/hup.2254.
PubMed 22996616
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Outpatients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01212575
- Acronym / sponsor ID
- NIS-NDK-SER-2010/2
- Conditions
- Schizophrenia
- Keywords
- Mental disorder, Antipsychotic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Sep 2010 (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 primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 300 patients | – | –Female or male aged 18-65 years with a diagnosis of schizophrenia having received at least one dose of Seroquel XR or Seroquel IR during January - March 2010 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of schizophrenia who are registered at an outpatient district psychiatric clinic
Key inclusion criteria (2 listed)
- Adults with a diagnosis of schizophrenia from a district psychiatric clinic in Denmark
- Patients who have received at least one dose of Seroquel XR or Seroquel IR during January - March 2010
Key exclusion criteria (1 listed)
- Patients already participating in a clinical study during the study-period.
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
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia
Time frame: Month 1
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia
Time frame: Month 2
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia
Time frame: Month 3
9 secondary outcomes
Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR
Time frame: Month 1
Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR
Time frame: Month 2
Co-morbidities of patients with schizophrenia receiving Seroquel XR and IR
Time frame: Month 3
Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics
Time frame: Month 1
Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics
Time frame: Month 2
Whether Seroquel XR and Seroquel IR are used to treat different types of outpatients with schizophrenia by evaluation of patient characteristics
Time frame: Month 3
The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Time frame: Month 1
The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Time frame: Month 2
The treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Time frame: Month 3
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 8 Mar 2011.
- Derived from this study: PubMed 22996616Emborg C, Hallerback T, Jorgensen L, Carlborg A. A retrospective study of clinical usage of quetiapine XR and quetiapine IR in outpatients with schizophrenia in Denmark. Hum Psychopharmacol. 2012 Sep;27(5):492-8. doi: 10.1002/hup.2254.
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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.
Eva Dencker Vansvik study director
AstraZeneca Nordic-Södertälje, Sweden
Charlotte Emborg principal investigator
Skovager 2, Risskov, Denmark
13 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, run by AstraZeneca at 13 sites in Denmark.
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 2 inclusion and 1 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 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Denmark. 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?
How Seroquel XR and Seroquel IR are used in the clinical practice of outpatients with schizophrenia (time frame: Month 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212575, which also lists 1 linked publication.
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 8 Mar 2011.