Quetiapine Efficacy in Bipolar Depression Study (QUEEN)

October 3, 2008 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Goyang-si
      • Kyungki-do, Goyang-si, Korea, Republic of
        • Research Site
    • Kwangyuk-si
      • Daejun, Kwangyuk-si, Korea, Republic of
        • Research Site
    • Suwon-si
      • Kyungki-do, Suwon-si, Korea, Republic of
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Joon-Woo Bahn, AstraZeneca Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 30, 2007

First Posted (Estimate)

August 31, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NKR-SER-2007/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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