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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Depression, Bipolar; Bipolar Disorder

Treatments: Drug: SEROQUEL (quetiapine fumarate) Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00060489

5077US/0049

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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