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

December 3, 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 2 Fixed Doses (50 mg, 100 mg) of Desvenlafaxine Sustained-Release Tablets in Adult Outpatients With Major Depressive Disorder

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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

  • Croatia
      • Rijeka, Croatia, 51000
      • Split, Croatia, 21000
      • Zagreb, Croatia, 10090
  • Estonia
      • Tallinn, Estonia, 126 18
      • Tartu, Estonia, 50407
      • Tartu, Estonia, 50417
  • Finland
      • Espoo, Finland, FIN-02650
      • Helsinki, Finland, FIN-00100
      • Helsinki, Finland, FIN-00260
      • Helsinki, Finland, FIN-00530
      • Joensuu, Finland, 80100
      • Kuopio, Finland, 70110
      • Oulu, Finland, 90 100
      • Rauma, Finland, 26100
      • Salo, Finland, 24100
      • Turku, Finland, SF-20100
  • France
      • Caen, France, 14000
      • Dole, France, 39100
      • Douai, France, 59500
      • Mulhouse, France, 68100
      • Orvault, France, 44700
      • Rennes, France, 35000
      • Tours, France, 37300
  • Latvia
      • Jelgava, Latvia, 3008
      • Liepaja, Latvia, 3401
      • Riga, Latvia, 1005
      • Strenci, Latvia, 4730
  • Lithuania
      • Kaunas, Lithuania, 50185
      • Klaipeda, Lithuania, 91251
      • Vilnius, Lithuania, 10204
  • Poland
      • Lubiaz, Poland, 56-100
      • Tuszyn, Poland, 95 080
      • Zuromin, Poland, 09-300
  • Romania
      • Bucuresti, Romania, 41914
      • Bucuresti, Romania, 60011
      • Craiova, Romania, 200738
  • Slovakia
      • Bojnice, Slovakia, 97201
      • Bratislava, Slovakia, 82606
      • Rimavska Sobota, Slovakia, 97901
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 9646
      • Durban, South Africa, 4058
      • Pretoria, South Africa, 157

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:

  • 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

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 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 Outcome Measures

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

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

Investigators

  • Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
  • Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Croatia, WPBUMED@wyeth.com
  • Principal Investigator: Trial Manager, For Finland, MedInfoNord@wyeth.com
  • Principal Investigator: Trial Manager, For Slovakia, DIS-WP-BV-EUBV01-Medical@wyeth.com
  • Principal Investigator: Trial Manager, For Romania, WPVIMED@wyeth.com
  • Principal Investigator: Trial Manager, For Estonia, Latvia, Lithuania, WPVIMED@wyeth.com

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

March 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 7, 2006

First Posted (Estimate)

March 8, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3151A1-333

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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