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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: Quetiapine Fumarate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00083954

D1447C00135

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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