Trial record 1 of 1 for:
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes
This study has been completed.
Information provided by:
First received: November 10, 2010
Last updated: March 28, 2011
Last verified: March 2011
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.
Acute Bipolar Manic Episode
||Observational Model: Cohort
Time Perspective: Retrospective
||European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine
Primary Outcome Measures:
- Length of hospital stay [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Use of resources [ Designated as safety issue: No ]
- Treatments used [ Designated as safety issue: No ]
- Demographics [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2011 (Final data collection date for primary outcome measure)
patients admitted as for an acute bipolar manic episode and treated with quetiapine IR
patients admitted as for an acute bipolar manic episode and treated with quetiapine XR
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01239589
No publications provided
||Medical Science Director, AstraZeneca
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 10, 2010
||March 28, 2011
||Belgium: Institutional Review Board
Croatia: Agency for Medicinal Product and Medical Devices
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices (informed)
Italy: Ethics Committee
Denmark: Danish Medicines Agency
Finland: Ethics Committee
Turkey: Ethics Committee (informed)
United Kingdom: Research Ethics Committee
Keywords provided by AstraZeneca:
Patients admitted as for an acute bipolar manic episode
Description of management patterns and hospital stay in patients admitted for acute bipolar manic episode and treated with either quetiapine IR or quetiapine XR
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2014
Affective Disorders, Psychotic
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents