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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: June 23, 2003
Last updated: August 18, 2009
Last verified: August 2009

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

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)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00063206

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00063206     History of Changes
Other Study ID Numbers: 3151A1-304
Study First Received: June 23, 2003
Last Updated: August 18, 2009

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

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on May 25, 2017