AZD7268 Safety and Tolerability Study

A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder

The purpose of this study is to prove the principle that treatment with AZD7268 reduces depressive symptoms in patients with Major Depressive Disorder (MDD) compared with placebo.

Inclusion Criteria:

• Provision of signed, written, and dated Informed Consent prior to any study specific procedures
• Documented primary clinical diagnosis meeting criteria from the DSM-IV, Text Revision (APA 2000) for any of the following:
• 296.2x Major Depressive Disorder, Single Episode, or
• 296.3x Major Depressive Disorder, Recurrent

Exclusion Criteria:

• Patients with a secondary DSM-IV Axis I disorder other than GAD or social anxiety disorder (as assessed by MINI), provided the primary diagnosis is MDD. This diagnosis should have been made at least 6 months before enrollment
• 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 started less than 4 weeks before enrollment