Study Evaluating DVS-233 in Adult Outpatients With Major Depressive Disorder
Phase 3
Completed
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00063206
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
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<sub>17</sub>)
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method