- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00990626
Seroquel XR in Schizophrenia Relapse Prevention
November 16, 2010 updated by: AstraZeneca
The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improve the relapse prevention in schizophrenic outpatients
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
1600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Baja, Hungary
- Research Site
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Barcs, Hungary
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Budapest, Hungary
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Cegled, Hungary
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Debrecen, Hungary
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Dombovar, Hungary
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Dunaujvaros, Hungary
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Eger, Hungary
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Egerszalok, Hungary
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Emod, Hungary
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Erd, Hungary
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Esztergom, Hungary
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Godollo, Hungary
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Gyongyos, Hungary
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Gyor, Hungary
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Gyula, Hungary
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Heves, Hungary
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Hodmezovasarhely, Hungary
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Janoshalma, Hungary
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Jaszbereny, Hungary
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Kalocsa, Hungary
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Kecskemet, Hungary
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Ketegyhaza, Hungary
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Kiskunhalas, Hungary
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Kistokaj, Hungary
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Miskolc, Hungary
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Nagyatad, Hungary
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Nagykallo, Hungary
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Nagykanizsa, Hungary
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Nagykoros, Hungary
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Oroshaza, Hungary
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Pecs, Hungary
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Pomaz, Hungary
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Satoraljaujhely, Hungary
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Soltvadkert, Hungary
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Sopron, Hungary
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Sumeg, Hungary
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Szeged, Hungary
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Szeghalom, Hungary
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Szekesfehervar, Hungary
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Szekszard, Hungary
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Szentes, Hungary
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Szigetszentmiklos, Hungary
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Szigetvar, Hungary
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Szolnok, Hungary
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Szombathely, Hungary
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Tatabanya, Hungary
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Veszprem, Hungary
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Psychiatric outpatient clinics
Description
Inclusion Criteria:
- Schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month
Exclusion Criteria:
- Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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1
Schizophrenic outpatients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Rate of patients remained relapse free after 6 months of treatment
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Secondary Outcome Measures
Outcome Measure |
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Adherence rate of patients
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Quality of Life (QoL )
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Attila Németh, National Psychiatric Centre
- Study Chair: Lilla Szabó, AstraZeneca Hungary MC
- Study Director: Tamás Bábel, AstraZeneca Hungary MC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 6, 2009
First Posted (Estimate)
October 7, 2009
Study Record Updates
Last Update Posted (Estimate)
November 17, 2010
Last Update Submitted That Met QC Criteria
November 16, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-NHU-SER-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.