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Trial record 1 of 1 for:    NIS-NEU-SER-2010/1
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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
  Purpose

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.


Condition
Acute Bipolar Manic Episode

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ]

Enrollment: 1280
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239589

  Show 86 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01239589     History of Changes
Other Study ID Numbers: NIS-NEU-SER-2010/1
Study First Received: November 10, 2010
Last Updated: March 28, 2011
Health Authority: 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:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013