Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 709
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of DVS SR (25 and 50 mg/day) in the treatment of adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 2: Desvenlafaxine Succinate Sustained-Release (DVS SR) intervention 3: placebo
Intervention descriptions: intervention 1: 25 mg tablet, once daily dosing for 8 weeks intervention 2: 50 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets (25 or 50 mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.

Protocol document: