Schizophrenia Relapse PreventionNCT00990626
Seroquel XR in Schizophrenia Relapse Prevention
An observational study of Schizophrenia Relapse Prevention, run by AstraZeneca at 48 sites in Hungary.
Trial summary
The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia Relapse Prevention
- How many people
- 1,600 participants
- Where
- 48 sitesHungary
- Study dates
- Oct 2009to Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Psychiatric outpatient clinics
Who may be able to join
- Schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month
Who cannot join
- Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Hungary48 sites
Research Site
Baja
Research Site
Barcs
Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Dombóvár
Research Site
Dunaújváros
Research Site
Eger
Research Site
Egerszalók
Research Site
Emőd
Research Site
Érd
Research Site
Esztergom
Research Site
Gödöllő
Research Site
Gyöngyös
Research Site
Győr
Research Site
Gyula
Research Site
Heves
Research Site
Hódmezővásárhely
Research Site
Jánoshalma
Research Site
Jászberény
Research Site
Kalocsa
Research Site
Kecskemét
Research Site
Kétegyháza
Research Site
Kiskunhalas
Research Site
Kistokaj
Research Site
Miskolc
Research Site
Nagyatád
Research Site
Nagykálló
Research Site
Nagykanizsa
Research Site
Nagykőrös
Research Site
Orosháza
Research Site
Pécs
Research Site
Pomáz
Research Site
Sátoraljaújhely
Research Site
Soltvadkert
Research Site
Sopron
Research Site
Sümeg
Research Site
Szeged
Research Site
Szeghalom
Research Site
Székesfehérvár
Research Site
Szekszárd
Research Site
Szentes
Research Site
Szigetszentmiklós
Research Site
Szigetvár
Research Site
Szolnok
Research Site
Szombathely
Research Site
Tatabánya
Research Site
Veszprém
About this study
The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients
- Conditions
- Schizophrenia Relapse Prevention
- Keywords
- Seroquel XR, schizophrenia relapse prevention
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 | Schizophrenic outpatients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients remained relapse free after 6 months of treatment
Secondary outcomes (2)
Adherence rate of patients
Quality of Life (QoL )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Relapse PreventionStudies 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
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Attila Németh, Principal investigator, National Psychiatric CentreLilla Szabó, Study chair, AstraZeneca Hungary MCTamás Bábel, Study director, AstraZeneca Hungary MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990626
- Sponsor's protocol ID
- NIS-NHU-SER-2009/1
- Status last verified
- Nov 2010
- First submitted
- 1 Oct 2009
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroquel XR in Schizophrenia Relapse Prevention
- ClinicalTrials.gov ID
- NCT00990626
- Acronym / sponsor ID
- NIS-NHU-SER-2009/1
- Conditions
- Schizophrenia Relapse Prevention
- Keywords
- Seroquel XR, schizophrenia relapse prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Oct 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.
The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Schizophrenic outpatients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Psychiatric outpatient clinics
Key inclusion criteria (1 listed)
- Schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month
Key exclusion criteria (1 listed)
- Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity
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
Rate of patients remained relapse free after 6 months of treatment
2 secondary outcomes
Adherence rate of patients
Quality of Life (QoL )
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 17 Nov 2010.
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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.
Attila Németh principal investigator
National Psychiatric Centre
Lilla Szabó study chair
AstraZeneca Hungary MC
Tamás Bábel study director
AstraZeneca Hungary MC
48 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 Relapse Prevention, run by AstraZeneca at 48 sites in Hungary.
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 1 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 17 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Hungary. 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?
Rate of patients remained relapse free after 6 months of treatment. 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 17 Nov 2010.