Study Evaluating Desvenlafaxine Sustained-Release (DVS-SR) in Adult Outpatients With Major Depressive Disorder

December 19, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

The purpose of this study is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS-SR versus subjects receiving placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
      • Northridge, California, United States, 91324
    • Connecticut
      • Farmington, Connecticut, United States, 06030
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Miami, Florida, United States, 33173
      • St. Petersburg, Florida, United States, 33702
    • Georgia
      • Marietta, Georgia, United States, 30060
      • Smyrna, Georgia, United States, 30080
    • Illinois
      • Libertyville, Illinois, United States, 60048
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
    • New Jersey
      • Clementon, New Jersey, United States, 08021
      • Moorestown, New Jersey, United States, 08057
    • New York
      • New York, New York, United States, 10021
      • New York, New York, United States, 10024
    • Ohio
      • Dayton, Ohio, United States, 45408
      • Toledo, Ohio, United States, 43623
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States, 29407
      • Columbia, South Carolina, United States, 29201
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of major depressive disorder
  • Must be able to swallow tablets
  • Must be at least 18 years of age.

Exclusion Criteria:

  • Clinical diagnosis of other psychiatric disorders
  • Significant risk of suicide
  • Unstable medical conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.

Secondary Outcome Measures

Outcome Measure
Additional objectives include testing both general and functional quality-of-life outcomes and satisfaction with therapy reported by the subject.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 19, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A1-332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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