Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders 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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Patient is able to provide written informed consent before beginning any study related procedures

• Patient has a documented clinical diagnosis of major depressive disorder

• Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Exclusion Criteria:

• Patients with a history of non-compliance as judged by the study investigator

• Patients with a known lack of response to previous treatment with quetiapine

• Patients who have participated in a clinical trial within 4 weeks of randomization