Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder.

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:

• Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.

Exclusion Criteria:

• The presence of dementia or mental disorder other than MDD within 6 months of enrolment,

• Uncontrolled hypertension, substance or alcohol abuse

• A current diagnosis of cancer or a current or past diagnosis of stroke