European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes

NCT ID: NCT01239589

Last Updated: 2011-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Bipolar Manic Episode

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

patients admitted as for an acute bipolar manic episode and treated with quetiapine IR

No interventions assigned to this group

2

patients admitted as for an acute bipolar manic episode and treated with quetiapine XR

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Locations

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Research Site

Lamezia Terme, Catanzaro, Italy

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Cosenza, Cosenza, Italy

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Assebroek, Belgium, Belgium

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Bertrix, Belgium, Belgium

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Bruges, Belgium, Belgium

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Ghent, Belgium, Belgium

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Godinne, Belgium, Belgium

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Ixelles-Elsene, Belgium, Belgium

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Koksijde, Belgium, Belgium

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Malle, Belgium, Belgium

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Marchienne-au-Pont, Belgium, Belgium

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Montignies-sur-Sambre, Belgium, Belgium

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Ottignies, Belgium, Belgium

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Overpelt, Belgium, Belgium

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Roeselaere, Belgium, Belgium

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Zagreb, City of Zagreb, Croatia

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Split, Split, Croatia

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Augustenborg, Augustenborg, Denmark

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Bispebjerg, Bispebjerg, Denmark

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Br�nderslev, Br�nderslev, Denmark

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Odense, Odense, Denmark

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Helsingin Kaupunki, Helsingin Kaupunki, Finland

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Jyv�skyl�, Jyv�skyl�, Finland

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Kellokoski, Kellokoski, Finland

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Ekenäs, Tammisaari, Finland

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Ulm, Baden-W�rttemberg, Germany

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Cham, Bavaria, Germany

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Neu�tting, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Wasserburg am Inn, Bavaria, Germany

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W�rzburg, Bavaria, Germany

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Bielefeld, Lower Saxony, Germany

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Hildesheim, Lower Saxony, Germany

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Liebenburg, Lower Saxony, Germany

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Greifswald, Mecklenburg-Vorpommern, Germany

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Bochum, North Rhine-Westphalia, Germany

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Berlin, State of Berlin, Germany

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Ascoli Piceno, Ascoli Piceno, Italy

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Bologna, Bologna, Italy

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Ceglie Messapica, Brindisi, Italy

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San Pietro Vernotico, Brindisi, Italy

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Cuneo, Cuneo, Italy

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Ferrara, Ferrara, Italy

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Foggia, Foggia, Italy

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Loc. S. Marciano (Sora), Frosinone, Italy

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S. Agata Militello, Messina, Italy

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Mestre, Mestre, Italy

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Pisa, Pisa, Italy

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Roma, Roma, Italy

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Sassari, Sassari, Italy

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Teramo, Teramo, Italy

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Conegliano, Treviso, Italy

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Adana, Adana, Turkey (Türkiye)

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Ankara, Ankara, Turkey (Türkiye)

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Ayd?n, Ayd?n, Turkey (Türkiye)

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Bolu, Bolu, Turkey (Türkiye)

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Diyarbakır, Diyarbakır, Turkey (Türkiye)

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Elâzığ, Elâzığ, Turkey (Türkiye)

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Erzurum, Erzurum, Turkey (Türkiye)

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Istanbul, Istanbul, Turkey (Türkiye)

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Kayseri, Kayseri, Turkey (Türkiye)

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Konya, Konya, Turkey (Türkiye)

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Manisa, Manisa, Turkey (Türkiye)

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Samsun, Samsun, Turkey (Türkiye)

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Sivas, Sivas, Turkey (Türkiye)

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Trabzon, Trabzon, Turkey (Türkiye)

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Zonguldak, Zonguldak Province, Turkey (Türkiye)

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Sanliurfa, Şanlıurfa, Turkey (Türkiye)

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Bury St Edmunds, Bury Saint Edmunds, United Kingdom

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Winsford, Cheshire, United Kingdom

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Coventry, Coventry, United Kingdom

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Hull, Hull, United Kingdom

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Dartford, Kent, United Kingdom

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Leeds, Leeds, United Kingdom

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Leicester, Leicester, United Kingdom

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Ealing, London, United Kingdom

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London, London, United Kingdom

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Prescot, Merseyside, United Kingdom

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Newcastle upon Tyne, Newcastle (Upon Tyne), United Kingdom

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Norwich, Norfolk, United Kingdom

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Taunton, Somerset, United Kingdom

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Cannock, Staffordshire, United Kingdom

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Chertsey, Surrey, United Kingdom

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Wolverhampton, West Midlands, United Kingdom

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Pulborough, West Sussex, United Kingdom

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Bradford, Yorkshire, United Kingdom

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Countries

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Belgium Croatia Denmark Finland Germany Italy Turkey (Türkiye) United Kingdom

References

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Karamustafalioglu O, Reif A, Atmaca M, Gonzalez D, Moreno-Manzanaro M, Gonzalez MA, Medina E, Bellomo A. Hospital stay in patients admitted for acute bipolar manic episodes prescribed quetiapine immediate or extended release: a retrospective non-interventional cohort study (HOME). BMC Psychiatry. 2014 Aug 31;14:246. doi: 10.1186/s12888-014-0246-3.

Reference Type DERIVED
PMID: 25174996 (View on PubMed)

Other Identifiers

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NIS-NEU-SER-2010/1

Identifier Type: -

Identifier Source: org_study_id

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