Overview

Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Phase:
Phase 3
Details
Lead Sponsor:
AstraZeneca
Treatments:
Lithium Carbonate
Quetiapine Fumarate
Valproic Acid