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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: DVS-233 SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090649

3151A1-309

Details and patient eligibility

About

To compare the antidepressant efficacy and safety of DVS-233 SR with those of placebo in adult outpatients with MDD.

Enrollment: 369 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women 18 to 75 years of age, inclusive.
• Sexually active individuals participating in the study must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article
• Subjects must have a primary diagnosis of major depressive disorder

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind