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Study Evaluating DVS-233 SR in Adult Outpatients With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00092911
First received: September 24, 2004
Last updated: August 18, 2009
Last verified: August 2009
History of Changes
  Purpose

The main objective of this study is to compare the antidepressant efficacy and safety of DVS-233 SR versus placebo in adult outpatients with Major Depressive Disorder.


Condition Intervention Phase
Depression
Depressive Disorder
Major Depressive Disorder
 Drug: DVS-233 SR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of a Flexible Dose of DVS-233 SR in Adult Outpatients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 244
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Men and women age 18 years of age and older
  • Women of childbearing potential participating in the study must have a negative serum pregnancy test result at screening and use a medically acceptable form of contraception

Exclusion Criteria:

  • Treatment with DVS-233 SR at any time in the past
  • Treatment with venlafaxine (immediate release [IR] or extended release [ER]) within 90 days of study day 1
  • Known hypersensitivity to venlafaxine (IR or ER)
  • Significant risk of suicide based on clinical judgment, including common
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092911

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00092911     History of Changes
Other Study ID Numbers: 3151A1-320
Study First Received: September 24, 2004
Last Updated: August 18, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013