Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression

Phase 3

Completed

• Conditions: Bipolar Disorder; Depression, Bipolar

• Registration Number: NCT00060489
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-05-06
• Study First Submitted QC: 2003-05-07
• Study First Posted: 2003-05-08
• Primary Completion: 2003-09
• Study Completion: 2003-09
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Written Informed Consent;
• Bipolar disorder with most recent episode depressed;
• Outpatient status

Exclusion Criteria

• Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
• Patients whose current episode of depression exceeds 12 months or is less than 4 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified