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

Wyeth is now a wholly owned subsidiary of Pfizer480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

480

Conditions

Depressive Disorder, Major

Interventions

desvenlafaxine 50 mgDRUG

desvenlafaxine 100 mgDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

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 Outcomes

The Global Clinical Improvement will be the key secondary efficacy variable.

Data from ClinicalTrials.gov

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