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

Condition(s) targeted: Bipolar Disorder; Depression, Bipolar

Intervention: SEROQUEL (quetiapine fumarate) Tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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.

Study design: Interventional, Treatment

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Birmingham, Alabama, United States

Beverly Hills, California, United States

La Mesa, California, United States

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Winter Park, Florida, United States

Atlanta, Georgia, United States

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Oakbrook, Illinois, United States

Shreveport, Louisiana, United States

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New York, New York, United States

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Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Dayton, Ohio, United States

Columbia, South Carolina, United States

Memphis, Tennessee, United States

Austin, Texas, United States

Salt Lake City, Utah, United States

Falls Church, Virginia, United States

Bellevue, Washington, United States

Kirkland, Washington, United States

Last updated: June 23, 2005