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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01239589

First received: November 10, 2010

Last updated: March 28, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 10, 2010
Last Updated Date	March 28, 2011
Start Date ^ICMJE	November 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 10, 2010)	Length of hospital stay [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01239589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 10, 2010)	Use of resources [ Designated as safety issue: No ] Treatments used [ Designated as safety issue: No ] Demographics [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes
Official Title ^ICMJE	European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition ^ICMJE	Acute Bipolar Manic Episode
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	1 patients admitted as for an acute bipolar manic episode and treated with quetiapine IR 2 patients admitted as for an acute bipolar manic episode and treated with quetiapine XR
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1280
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Croatia, Denmark, Finland, Germany, Italy, Turkey, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01239589
Other Study ID Numbers ^ICMJE	NIS-NEU-SER-2010/1
Has Data Monitoring Committee	No
Responsible Party	Medical Science Director, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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