Clinical Trial: Phase 3 /Seroquel SR Acute Mania Monotherapy - US

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adul

Brief 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 Mania for 3 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Change from baseline to final visit in the YMRS total score

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: January 12, 2007
Date Started: January 2007
Date Completion:
Last Updated: March 24, 2009
Last Verified: March 2009