Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

Phase 3

Completed

• Conditions: Bipolar Disorder

• Registration Number: NCT00083954
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-06-03
• Study First Submitted QC: 2004-06-04
• Study First Posted: 2004-06-07
• Study Completion: 2005-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

• Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion Criteria

• More than 8 mood episodes in the past year from screen (visit 1);
• A current Axis I disorder other than bipolar disorder within 6 months of screening;
• patients with clinically significant abnormal laboratory findings in the investigator's judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

Name	Time	Method
Evaluate the incidence of treatment-emergent mania compared to placebo

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States