drugset / Trial / NCT01256177

Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

NCT01256177

Phase 3 Completed 361 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Timeline

Start
2010-12
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule 300 mg Oral

Indications