Study Evaluating DVS-233 SR in Adult Outpatients With Major Depressive Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.

Inclusion Criteria:

• Outpatients
• Men and women age 18 years of age and older
• Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

Exclusion Criteria:

• Treatment with DVS-233 SR at any time in the past
• Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
• Known hypersensitivity to venlafaxine (IR or ER)
• Significant risk of suicide based on clinical judgment, including common