Quetiapine Efficacy in Bipolar Depression Study

NCT ID: NCT00523601

Last Updated: 2008-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2007-12-31

Brief Summary

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

Conditions

Bipolar Depression

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

Joon-Woo Bahn

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

Research Site

Kyungki-do, Goyang-si, South Korea

Research Site

Daejun, Kwangyuk-si, South Korea

Research Site

Kyungki-do, Suwon-si, South Korea

Countries

South Korea

Other Identifiers

NIS-NKR-SER-2007/2

Identifier Type: -

Identifier Source: org_study_id