drugset / Trial / NCT00883493

Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

NCT00883493

Phase 3 Completed 421 enrolled AstraZeneca
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Timeline

Start
2009-04
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lithium Unknown 600 mg
Subject Lithium Unknown 1800 mg
Subject Quetiapine Small molecule 300 mg Oral

Indications