SchizophreniaNCT00750087
Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR
An observational study of Schizophrenia, run by AstraZeneca at 32 sites in Romania.
Trial summary
the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia
- How many people
- 578 participants
- Where
- 32 sitesRomania
- Study dates
- Aug 2008to Sep 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The programme will include schizophrenia patients stabilized on Seroquel XR from community sample
Who may be able to join
- Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
- All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.
Who cannot join
- All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
- As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Romania32 sites
Research Site
Alba
Research Site
Arad
Research Site
Bacau
Research Site
Baia Mare
Research Site
Bistriţa
Research Site
Botoșani
Research Site
Brăila
Research Site
Brasov
Research Site
Bucharest
Research Site
Calarasi
Research Site
Câmpina
Research Site
Cluj-Napoca
Research Site
Constanța
Research Site
Craiova
Research Site
Deva
Research Site
Galati
Research Site
Giurgiu
Research Site
Horezu
Research Site
Iași
Research Site
Oradea
Research Site
Piteşti
Research Site
Ploieşti
Research Site
Râmnicu Vâlcea
Research Site
Satu Mare
Research Site
Sibiu
Research Site
Siret
Research Site
Slatina
Research Site
Slobozia
Research Site
Targoviste
Research Site
Târgu Mureş
Research Site
Timișoara
Research Site
Zalău
About this study
Official title: Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Schizophrenia
- Keywords
- 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 | Schizophrenia patients stabilized on Seroquel XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale - BPRS
Measured: monthly/ at every clinic visit- 7 times
Secondary outcomes (3)
Clinical Global Impression Severity of Illness - CGI -S
Measured: monthly/ at every clinic visit- 7 times
Clinical Global Impression Improvement CGI -I
Measured: monthly/ at every clinic visit except first visit- 6 times
Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)
Measured: twice/first and last clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionSep 2009
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
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Beatrice Costea, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750087
- Sponsor's protocol ID
- NIS-NRO-SER-2008/1
- Status last verified
- Feb 2010
- First submitted
- 9 Sep 2008
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
- ClinicalTrials.gov ID
- NCT00750087
- Acronym / sponsor ID
- NIS-NRO-SER-2008/1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Sep 2008 (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 purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Schizophrenia patients stabilized on Seroquel XR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The programme will include schizophrenia patients stabilized on Seroquel XR from community sample
Key inclusion criteria (2 listed)
- Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before
- All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.
Key exclusion criteria (2 listed)
- All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study.
- As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.
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
Brief Psychiatric Rating Scale - BPRS
Time frame: monthly/ at every clinic visit- 7 times
3 secondary outcomes
Clinical Global Impression Severity of Illness - CGI -S
Time frame: monthly/ at every clinic visit- 7 times
Clinical Global Impression Improvement CGI -I
Time frame: monthly/ at every clinic visit except first visit- 6 times
Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)
Time frame: twice/first and last clinic visit
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 5 Feb 2010.
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Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
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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.
Beatrice Costea study chair
AstraZeneca
32 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 32 sites in Romania.
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 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 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Romania. 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?
Brief Psychiatric Rating Scale - BPRS (time frame: monthly/ at every clinic visit- 7 times). 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 5 Feb 2010.