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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01239589
Other study ID # NIS-NEU-SER-2010/1
Secondary ID
Status Completed
Phase N/A
First received November 10, 2010
Last updated March 28, 2011
Start date November 2010
Est. completion date March 2011

Study information

Verified date March 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review BoardCroatia: Agency for Medicinal Product and Medical DevicesGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices (informed)Italy: Ethics CommitteeDenmark: Danish Medicines AgencyFinland: Ethics CommitteeTurkey: Ethics Committee (informed)United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1280
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium Research Site Assebroek
Belgium Research Site Bertrix
Belgium Research Site Brugge
Belgium Research Site Elsene
Belgium Research Site Gent
Belgium Research Site Godinne
Belgium Research Site Koksijde
Belgium Research Site Malle
Belgium Research Site Marchienne-au-Pont
Belgium Research Site Montignies-Sur-Sambre
Belgium Research Site Ottignies
Belgium Research Site Overpelt
Belgium Research Site Roeselaere
Croatia Research Site Split
Croatia Research Site Zagreb
Denmark Research Site Augustenborg
Denmark Research Site Bispebjerg
Denmark Research Site Br?nderslev
Denmark Research Site Odense
Finland Research Site Helsingin Kaupunki
Finland Research Site Jyv?skyl?
Finland Research Site Kellokoski
Finland Research Site Tammisaari
Germany Research Site Berlin
Germany Research Site Bielefeld Niedersachsen
Germany Research Site Bochum Nordrhein-Westfalen
Germany Research Site Cham Bayern
Germany Research Site Greifswald Mecklenburg- Vorpommern
Germany Research Site Hildesheim Niedersachsen
Germany Research Site Liebenburg Niedersachsen
Germany Research Site Neu?tting Bayern
Germany Research Site Regensburg Bayern
Germany Research Site Ulm Baden-W?rttemberg
Germany Research Site W?rzburg Bayern
Germany Research Site Wasserburg am Inn Bayern
Italy Research Site Ascoli Piceno
Italy Research Site Bologna
Italy Research Site Ceglie Messapica Brindisi
Italy Research Site Conegliano Treviso
Italy Research Site Cosenza
Italy Research Site Cuneo
Italy Research Site Ferrara
Italy Research Site Foggia
Italy Research Site Lamezia Terme Catanzaro
Italy Research Site Loc. S. Marciano (Sora) Frosinone
Italy Research Site Mestre
Italy Research Site Pisa
Italy Research Site Roma
Italy Research Site S. Agata Militello Messina
Italy Research Site San Pietro Vernotico Brindisi
Italy Research Site Sassari
Italy Research Site Teramo
Turkey Research Site Adana
Turkey Research Site Ankara
Turkey Research Site Ayd?n
Turkey Research Site Bolu
Turkey Research Site Diyarbakir
Turkey Research Site Elazig
Turkey Research Site Erzurum
Turkey Research Site Istanbul
Turkey Research Site Kayseri
Turkey Research Site Konya
Turkey Research Site Manisa
Turkey Research Site Samsun
Turkey Research Site Sanliurfa
Turkey Research Site Sivas
Turkey Research Site Trabzon
Turkey Research Site Zonguldak
United Kingdom Research Site Bradford Yorkshire
United Kingdom Research Site Bury St Edmunds
United Kingdom Research Site Cannock Staffordshire
United Kingdom Research Site Chertsey Surrey
United Kingdom Research Site Coventry
United Kingdom Research Site Dartford Kent
United Kingdom Research Site Ealing London
United Kingdom Research Site Hull
United Kingdom Research Site Leeds
United Kingdom Research Site Leicester
United Kingdom Research Site London
United Kingdom Research Site Newcastle (Upon Tyne)
United Kingdom Research Site Norwich Norfolk
United Kingdom Research Site Prescot Merseyside
United Kingdom Research Site Pulborough West Sussex
United Kingdom Research Site Taunton Somerset
United Kingdom Research Site Winsford Cheshire
United Kingdom Research Site Wolverhampton West Midlands

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Croatia,  Denmark,  Finland,  Germany,  Italy,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospital stay No
Secondary Use of resources No
Secondary Treatments used No
Secondary Demographics No