Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder

To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of 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.

Inclusion Criteria:

• Male or female aged 18 to 65 years
• A documented diagnosis of major depressive disorder

Exclusion Criteria:

• Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
• Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
• Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment