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Study Evaluating DVS-233 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:
NCT00063206
First received: June 23, 2003
Last updated: August 18, 2009
Last verified: August 2009
History of Changes
  Purpose

Primary: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general well-being, pain, and remission (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D<sub>17</sub>] < 7) versus those subjects receiving placebo.


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

Study Type: Interventional
Study Design: 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: 247
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have a primary diagnosis of major depressive disorder (MDD)
  • Depressive symptoms for at least 30 days prior to the screening visit
  • Minimum screening and study day -1 (baseline) scores of 20 on the Hamilton Psychiatric Rating Scale for Depression (HAM D<sub>17</sub>)

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063206

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 by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00063206     History of Changes
Other Study ID Numbers: 3151A1-304
Study First Received: June 23, 2003
Last Updated: August 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Depressive Disorder, Major
Depression, Involutional

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

ClinicalTrials.gov processed this record on May 19, 2013