drugset / Trial / NCT00314184

Quetiapine Fumarate Bipolar Maintenance Monotherapy

NCT00314184

Phase 3 Completed 1255 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. 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
2005-03
Primary completion
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule

Indications