Study Evaluating DVS-233 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

NCT00063206

3151A1-304

Details and patient eligibility

About

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

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D₁₇] < 7) versus those subjects receiving placebo.

Enrollment: 247 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have a primary diagnosis of major depressive disorder (MDD)
• Depressive symptoms for at least 30 days prior to the screening visit
• Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D₁₇)

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)