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
  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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar depression
quetiapine
observational
Naturalistic
Observational

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Quetiapine
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014