Major Depressive Disorder
Conditions
Keywords
Depression, Adult, Outpatients
Brief summary
The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.
Interventions
DRUGDVS-SR 50 mg
DRUGDVS-SR 100 mg
DRUGPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of major depressive disorder * Must be able to swallow tablets * Must be at least 18 years of age.
Exclusion criteria
* Clinical diagnosis of other psychiatric disorders * Significant risk of suicide * Unstable medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject. | — |
Countries
United States
Outcome results
None listed