A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

Wyeth is now a wholly owned subsidiary of Pfizer0 sites480 target enrollmentMarch 2006

ConditionsDepressive Disorder, Major

Drugsdesvenlafaxine 50 mg desvenlafaxine 100 mg

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Depressive Disorder, Major
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 480
Primary Endpoint: 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
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

January 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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

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