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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

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