Study Evaluating the Efficacy and Safety of Desvenlafaxine Tablets in Adult Outpatients With Major Depressive Disorder

Wyeth

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: desvenlafaxine 50 mg; Drug: desvenlafaxine 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00300378

3151A1-333

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind