SchizophreniaNCT00981123
Non-interventional (NI) Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia
An observational study of Schizophrenia, run by AstraZeneca at 18 sites in Croatia.
Trial summary
Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 500 participants
- Where
- 18 sitesCroatia
- Study dates
- Sep 2009to Apr 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients or hospitalised patients
Who may be able to join
- Patients with diagnosis of schizophrenia
- Patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients)
- Patients capable of signing ICF
Who cannot join
- Patients with hypersensitivity to active substance or any of the excipients of this product
- Patients with contraindication for quetiapine therapy according to the approved SmPC
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Croatia18 sites
Research Site
Bjelovar
Research Site
Čakovec
Research Site
Dubrovnik
Research Site
Karlovac
Research Site
Osijek
Research Site
Popovača
Research Site
Pula
Research Site
Rijeka
Research Site
Šibenik
Research Site
Sisak
Research Site
Slavonski Brod
Research Site
Split
Research Site
Varaždin
Research Site
Vinkovci
Research Site
Vukovar
Research Site
Zabok
Research Site
Zadar
Research Site
Zagreb
About this study
Official title: Non-interventional Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia
Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using Clinical Global Impression (CGI) scale.
- Conditions
- Schizophrenia
- 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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale
Measured: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
Secondary outcomes (6)
To measure therapeutic response in schizophrenic patients using BPRS scale
Measured: BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy)
To evaluate compliance with the prescribed antipsychotic treatment
Measured: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia
Measured: 3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy)
To evaluate type and frequency of concomitant therapy
Measured: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy
To evaluate average number of hospitalisations
Measured: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations
To evaluate frequency of mental illnesses in patient's family
Measured: at visit 1 (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ana Marija Gjurovic, MD, MSc, Study director, AstraZeneca Medical DepartmentAndreja Hasenohrl, DVM, Study chair, AstraZeneca Medical Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981123
- Sponsor's protocol ID
- NIS-NHR-SER-2009/1
- Status last verified
- Jan 2011
- First submitted
- 14 Sep 2009
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia
- ClinicalTrials.gov ID
- NCT00981123
- Acronym / sponsor ID
- NIS-NHR-SER-2009/1
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Sep 2009 (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.
Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using Clinical Global Impression (CGI) scale.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients or hospitalised patients
Key inclusion criteria (3 listed)
- Patients with diagnosis of schizophrenia
- Patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients)
- Patients capable of signing ICF
Key exclusion criteria (2 listed)
- Patients with hypersensitivity to active substance or any of the excipients of this product
- Patients with contraindication for quetiapine therapy according to the approved SmPC
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
To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale
Time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
6 secondary outcomes
To measure therapeutic response in schizophrenic patients using BPRS scale
Time frame: BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy)
To evaluate compliance with the prescribed antipsychotic treatment
Time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)
To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia
Time frame: 3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy)
To evaluate type and frequency of concomitant therapy
Time frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy
To evaluate average number of hospitalisations
Time frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations
To evaluate frequency of mental illnesses in patient's family
Time frame: at visit 1 (day 0)
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 10 Jan 2011.
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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.
Ana Marija Gjurovic, MD, MSc study director
AstraZeneca Medical Department
Andreja Hasenohrl, DVM study chair
AstraZeneca Medical Department
18 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 18 sites in Croatia.
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 2 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 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Croatia. 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?
To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale (time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)). 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 10 Jan 2011.