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Quetiapine Efficacy in Bipolar Depression Study (QUEEN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523601
First Posted: August 31, 2007
Last Update Posted: October 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression

Condition
Bipolar Depression

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A 8-Week, Multicenter, Open-Label, Observational Study of the Efficacy of Quetiapine Fumarate (SEROQUEL) Immediate-Release Tablets in Adult Patients With Bipolar Depression

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 2000
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523601


Locations
Korea, Republic of
Research Site
Kyungki-do, Goyang-si, Korea, Republic of
Research Site
Daejun, Kwangyuk-si, Korea, Republic of
Research Site
Kyungki-do, Suwon-si, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon-Woo Bahn AstraZeneca Korea
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00523601     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2007/2
First Submitted: August 29, 2007
First Posted: August 31, 2007
Last Update Posted: October 6, 2008
Last Verified: April 2008

Keywords provided by AstraZeneca:
Bipolar depression
quetiapine
observational
Naturalistic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs