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Quetiapine Efficacy in Bipolar Depression Study (QUEEN)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: August 29, 2007
Last updated: October 3, 2008
Last verified: April 2008
To reassure the clinical study data on Seroquel antidepressant efficacy in patients who are diagnosed as bipolar depression

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)

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information: Identifier: NCT00523601     History of Changes
Other Study ID Numbers: NIS-NKR-SER-2007/2
Study First Received: August 29, 2007
Last Updated: October 3, 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 processed this record on September 21, 2017