Quetiapine Efficacy in Bipolar Depression Study (QUEEN)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00523601
First received: August 29, 2007
Last updated: October 3, 2008
Last verified: April 2008

August 29, 2007
October 3, 2008
June 2007
October 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00523601 on ClinicalTrials.gov Archive Site
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Quetiapine Efficacy in Bipolar Depression Study
A 8-Week, Multicenter, Open-Label, Observational Study of the Efficacy of Quetiapine Fumarate (SEROQUEL) Immediate-Release Tablets in Adult Patients With Bipolar Depression

To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression

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Observational
Time Perspective: Prospective
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Bipolar Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
December 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
  • Meet DSM-IV-TR criteria for bipolar depression at the time of baseline

Exclusion Criteria:

  • Since this programme intends to describe quetiapine use in routine clinical practice when prescribed as treatment of bipolar depression, there are no programme specific exclusion criteria, other than:

Or, any of the following is regarded as a criterion for exclusion from the programme:

  1. Serious or unstable, medical illness. Subjects with chronic illness may be included but must be stable and otherwise physically healthy on the basis of a physical examination, medical history
  2. Known intolerance for or lack of response to quetiapine, as judged by the investigator
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00523601
NIS-NKR-SER-2007/2
No
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AstraZeneca
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Study Director: Joon-Woo Bahn AstraZeneca Korea
AstraZeneca
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP