Depressive Disorder, Major
Conditions
Keywords
Depression, Adult, Outpatients
Brief summary
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS SR versus placebo in subjects with Major Depressive Disorder. Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.
Interventions
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
* A primary diagnosis of MDD * Depressive symptoms for at least 30 days before the screening visit.
Exclusion criteria
* Treatment with DVS SR at any time in the past. * Known hypersensitivity to venlafaxine * Significant risk of suicide based on clinical judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable will be the change from baseline on the 17-item of the Hamilton Depression rating scale (HAM-D17 score) at the final on therapy evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| The Global Clinical Improvement will be the key secondary efficacy variable. | — |
Countries
Croatia, Estonia, Finland, France, Latvia, Lithuania, Poland, Romania, Slovakia, South Africa
Outcome results
None listed