NCT00063206CompletedPhase 3
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
Wyeth is now a wholly owned subsidiary of Pfizer0 sites247 target enrollmentStarted: June 25, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 247
Study Overview
Brief Summary
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-D<sub>17</sub>] < 7) versus those subjects receiving placebo.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 D\17\)
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)
Investigators
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