Quetiapine Efficacy in Bipolar Depression Study (QUEEN)

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. Identifier: NCT00523601
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : October 6, 2008
Information provided by:

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

Condition or disease
Bipolar Depression

Study Type : Observational
Estimated Enrollment : 2000 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00523601

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
Study Director: Joon-Woo Bahn AstraZeneca Korea

Additional Information: Identifier: NCT00523601     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2007/2
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: October 6, 2008
Last Verified: April 2008

Keywords provided by AstraZeneca:
Bipolar depression

Additional relevant MeSH terms:
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