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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Fixed Doses (200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.

Inclusion Criteria:

• Outpatients
• Sexually active women participating in the study must use a medically acceptable form of contraception
• Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

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)