- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01239589
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes
March 28, 2011 updated by: AstraZeneca
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine
This study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine Extended Release (XR) in the hospital setting in real life practice, including length of stay.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1280
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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Assebroek, Belgium
- Research Site
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Bertrix, Belgium
- Research Site
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Brugge, Belgium
- Research Site
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Elsene, Belgium
- Research Site
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Gent, Belgium
- Research Site
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Godinne, Belgium
- Research Site
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Koksijde, Belgium
- Research Site
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Malle, Belgium
- Research Site
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Marchienne-au-Pont, Belgium
- Research Site
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Montignies-Sur-Sambre, Belgium
- Research Site
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Ottignies, Belgium
- Research Site
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Overpelt, Belgium
- Research Site
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Roeselaere, Belgium
- Research Site
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Split, Croatia
- Research Site
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Zagreb, Croatia
- Research Site
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Augustenborg, Denmark
- Research Site
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Bispebjerg, Denmark
- Research Site
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Br�nderslev, Denmark
- Research Site
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Odense, Denmark
- Research Site
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Helsingin Kaupunki, Finland
- Research Site
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Jyv�skyl�, Finland
- Research Site
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Kellokoski, Finland
- Research Site
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Tammisaari, Finland
- Research Site
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Berlin, Germany
- Research Site
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Baden-W�rttemberg
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Ulm, Baden-W�rttemberg, Germany
- Research Site
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Bayern
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Cham, Bayern, Germany
- Research Site
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Neu�tting, Bayern, Germany
- Research Site
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Regensburg, Bayern, Germany
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Wasserburg am Inn, Bayern, Germany
- Research Site
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W�rzburg, Bayern, Germany
- Research Site
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Mecklenburg- Vorpommern
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Greifswald, Mecklenburg- Vorpommern, Germany
- Research Site
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Niedersachsen
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Bielefeld, Niedersachsen, Germany
- Research Site
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Hildesheim, Niedersachsen, Germany
- Research Site
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Liebenburg, Niedersachsen, Germany
- Research Site
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Nordrhein-Westfalen
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Bochum, Nordrhein-Westfalen, Germany
- Research Site
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Ascoli Piceno, Italy
- Research Site
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Bologna, Italy
- Research Site
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Cosenza, Italy
- Research Site
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Cuneo, Italy
- Research Site
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Ferrara, Italy
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Foggia, Italy
- Research Site
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Mestre, Italy
- Research Site
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Pisa, Italy
- Research Site
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Roma, Italy
- Research Site
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Sassari, Italy
- Research Site
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Teramo, Italy
- Research Site
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Brindisi
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Ceglie Messapica, Brindisi, Italy
- Research Site
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San Pietro Vernotico, Brindisi, Italy
- Research Site
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Catanzaro
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Lamezia Terme, Catanzaro, Italy
- Research Site
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Frosinone
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Loc. S. Marciano (Sora), Frosinone, Italy
- Research Site
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Messina
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S. Agata Militello, Messina, Italy
- Research Site
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Treviso
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Conegliano, Treviso, Italy
- Research Site
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Adana, Turkey
- Research Site
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Ankara, Turkey
- Research Site
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Ayd?n, Turkey
- Research Site
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Bolu, Turkey
- Research Site
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Diyarbakir, Turkey
- Research Site
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Elazig, Turkey
- Research Site
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Erzurum, Turkey
- Research Site
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Istanbul, Turkey
- Research Site
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Kayseri, Turkey
- Research Site
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Konya, Turkey
- Research Site
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Manisa, Turkey
- Research Site
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Samsun, Turkey
- Research Site
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Sanliurfa, Turkey
- Research Site
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Sivas, Turkey
- Research Site
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Trabzon, Turkey
- Research Site
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Zonguldak, Turkey
- Research Site
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Bury St Edmunds, United Kingdom
- Research Site
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Coventry, United Kingdom
- Research Site
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Hull, United Kingdom
- Research Site
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Leeds, United Kingdom
- Research Site
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Leicester, United Kingdom
- Research Site
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London, United Kingdom
- Research Site
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Newcastle (Upon Tyne), United Kingdom
- Research Site
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Cheshire
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Winsford, Cheshire, United Kingdom
- Research Site
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Kent
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Dartford, Kent, United Kingdom
- Research Site
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London
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Ealing, London, United Kingdom
- Research Site
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Merseyside
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Prescot, Merseyside, United Kingdom
- Research Site
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Norfolk
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Norwich, Norfolk, United Kingdom
- Research Site
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Somerset
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Taunton, Somerset, United Kingdom
- Research Site
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Staffordshire
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Cannock, Staffordshire, United Kingdom
- Research Site
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Surrey
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Chertsey, Surrey, United Kingdom
- Research Site
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West Midlands
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Wolverhampton, West Midlands, United Kingdom
- Research Site
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West Sussex
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Pulborough, West Sussex, United Kingdom
- Research Site
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Yorkshire
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Bradford, Yorkshire, United Kingdom
- Research Site
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients diagnosed with Bipolar Disorder (ICD-10).admitted
due to a acute manic episode and treated with quetiapine IR or quetiapine XR during the hospitalization period
Description
Inclusion Criteria:
- Patients diagnosed with Bipolar Disorder (ICD-10).
- Admitted for acute bipolar manic episode from 1st October 2009 to 1st October 2010
- Patients treated with quetiapine IR or quetiapine XR during the hospitalization period.
Exclusion Criteria:
- Patients in which BD is not the main reason for hospitalization
- Patients admitted for acute bipolar mania episodes but finally diagnosed with mixed or bipolar disorder not otherwise specified (NOS) episodes
- Patients receiving both quetiapine IR and XR during the same hospitalization period.
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
Cohorts and Interventions
Group / Cohort |
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patients admitted as for an acute bipolar manic episode and treated with quetiapine IR
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2
patients admitted as for an acute bipolar manic episode and treated with quetiapine XR
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Length of hospital stay
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Secondary Outcome Measures
Outcome Measure |
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Demographics
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Use of resources
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Treatments used
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 10, 2010
First Submitted That Met QC Criteria
November 10, 2010
First Posted (Estimate)
November 11, 2010
Study Record Updates
Last Update Posted (Estimate)
March 29, 2011
Last Update Submitted That Met QC Criteria
March 28, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-NEU-SER-2010/1
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.
Clinical Trials on Acute Bipolar Manic Episode
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Johnson & Johnson Pharmaceutical Research & Development...Completed
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Dongbin LyuRecruiting
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Johnson & Johnson Pharmaceutical Research & Development...Completed
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Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SCompletedBipolar I Disorder | Manic EpisodeUnited States, Croatia, Ukraine
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Otsuka Pharmaceutical Development & Commercialization...H. Lundbeck A/SCompletedBipolar I Disorder | Manic EpisodeSerbia, United States, Bulgaria, Poland
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Mayo ClinicRecruiting
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Academisch Medisch Centrum - Universiteit van Amsterdam...University of Alberta; The University of Texas at Dallas; Parnassia Groep; EnLi...Not yet recruitingBipolar and Related Disorders | Psychosis | Schizophrenia and Related Disorders | Depressive Episode | Manic Episode
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Eli Lilly and CompanyCompletedManic or Mixed Episode Associated With Bipolar I DisorderJapan
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Otsuka Pharmaceutical Development & Commercialization...TerminatedAdolescent Schizophrenia | Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic FeaturesIndia, United States, Bulgaria, Croatia, Hungary, Malaysia, Philippines, Poland, Romania, Russian Federation, Serbia, Taiwan, Ukraine
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Max-Planck-Institute of PsychiatryCompletedSchizophrenia | Schizoaffective Disorder | Delusional Disorder | Schizotypal Disorder | Brief Psychotic Disorder | Shared Psychotic Disorder | Other Psychotic Disorder Not Due to A Substance or Known Physiological Condition | Unspecified Psychosis Not Due to a Substance or Known Physiological Condition and other conditionsGermany