drugset / Trial / NCT00422214

Phase III/Seroquel SR Bipolar Depression Monotherapy - US

NCT00422214

Phase 3 Completed 400 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Timeline

Start
2006-12
Primary completion
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule