Clinical Trial: Multiphase Efficacy Study of venlafaxine ER to Treat Recurrent Depression

This study is no longer recruiting patients.

Sponsored by: Wyeth
Information provided by: Wyeth

Purpose

The purpose of this study is to review the long-term comparative efficacy of venlafaxine ER in achieving and sustaining remission (wellness) in patients with recurrent major depression

Condition Treatment or Intervention Phase
Depression
 Drug: Venlafaxine ER
Phase IV

MedlinePlus related topics:  Depression

Study Type: Interventional
Study Design: Treatment

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

  • Clinical diagnosis for recurrent major depression

Exclusion Criteria

  • The patient has failed on an adequate trial of fluoxetine, venlafaxine or venlafaxine ER during the current episode of major depression or the patient is treatment-resistant
  • Known hypersensitivity to venlafaxine or fluoxetine
  • History or presence of clinically significant hepatic, cardiovascular or renal disease, or other serious medical disease, including history of seizure disorder
  • History or presence of bipolar disorder or eating disorder, or significant personality disorders or mental retardation (Axis II disorders) which would interfere with participation in the study
  • Patients diagnosed with panic disorder, obsessive compulsive disorder, generalized anxiety disorder, social phobia, PTSD within 6 months prior to screening, or current postpartum depression
  • History or presence of any psychotic disorder, including psychotic depression, or history or presence of any organic mental disorder
  • The patient has had a diagnosis of cancer in the past 3 years (excluding squamous or basal cell carcinoma)
  • The patient has dysphagia or difficulty swallowing tablets or capsules
  • Pregnant or breast-feeding women
  • The patient has any clinically significant condition that would, in the Investigator�s opinion, preclude study participation

Location Information


Alabama
      Birmingham Psychiatry Pharmaceutical Studies Inc., Birmingham,  Alabama,  35209,  United States

Arizona
      University of Arizona, Tucson,  Arizona,  85724,  United States

California
      Synergy Clinical Research Center, Chula Vista,  California,  91910,  United States

      Stanford University School of Medicine, Stanford,  California,  95305,  United States

      Pharmacology Research Institute - Newport, Newport Beach,  California,  92660,  United States

      Synergy Clinical Research Center, San Diego,  California,  92120,  United States

      Pharmacology Research Institute, Riverside,  California,  92056,  United States

      Pharmacology Research Institute, Los Alamitos,  California,  90720,  United States

      Pharmacology Research Institute, Northridge,  California,  91324,  United States

Florida
      Boca Raton Medical Research, Inc., Boca Raton,  Florida,  33433,  United States

      Irving S. Kolin, M.D., P.A., Winter Park,  Florida,  32789,  United States

Georgia
      Emory University, Dept of Psychiatry and Behavioral Sciences, Atlanta,  Georgia,  30329,  United States

Illinois
      Rush-Presbyterian/St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States

      Henry Lahmeyer, MD, Northfield,  Illinois,  60083,  United States

      Rush-Presbyterian/St. Luke's Medical Center, Skokie,  Illinois,  60076,  United States

      Rush Presbyterian/St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States

Massachusetts
      University of MA Mental Health Care, Worcester,  Massachusetts,  01605,  United States

Michigan
      Institute for Health Studies, Okemos,  Michigan,  48864,  United States

      Institute for Health Studies, Farmington Hills,  Michigan,  78336,  United States

New Jersey
      Center for Emotional Fitness, Moorestown,  New Jersey,  08057,  United States

New Mexico
      University of New Mexico Health Science Center, Albuquerque,  New Mexico,  87131,  United States

New York
      Cornell Medical Center, New York,  New York,  10021,  United States

North Carolina
      Weisler and Associates, Raleigh,  North Carolina,  27612,  United States

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  45237,  United States

      North Coast Clinical Trials, Beachwood,  Ohio,  44122,  United States

Oklahoma
      Pahl Brain Associates, P.C., Oklahoma City,  Oklahoma,  73118,  United States

Oregon
      Summit Research Network (Oregon), Portland,  Oregon,  97209,  United States

      Islan Park Professional Center, Springfield,  Oregon,  97477,  United States

Pennsylvania
      University of Pittsburgh, Western Psychiatric Institute and Clinic, Pittsburgh,  Pennsylvania,  15213,  United States

      Delaware Valley Research Associates, Inc., Conshohocken,  Pennsylvania,  19428,  United States

      Lansdale Medical Group, Lansdale,  Pennsylvania,  19446,  United States

Rhode Island
      Rhode Island Hospital, Mood Disorders Program, Providence,  Rhode Island,  02903,  United States

Tennessee
      Vanderbilt University Medical Center, Nashville,  Tennessee,  37212,  United States

Texas
      University of Texas Medical Branch, Dept of Psychiatry, Galveston,  Texas,  77555,  United States

      University of Texas Southwestern Medical Center, Dallas, Dallas,  Texas,  75235,  United States

      R/D Clinical Research, Inc., Lake Jackson,  Texas,  77566,  United States

      Community Clinical Research, Inc., Austin,  Texas,  78756,  United States

Utah
      Pharmacology Research Clinic, Salt Lake City,  Utah,  84107,  United States

Virginia
      Virginia Commonwealth University, Richmond,  Virginia,  23220,  United States

Washington
      University of Washington, Dept of Psychiatry, Center for Anxiety and Depression, Seattle,  Washington,  98105,  United States

Wisconsin
      University of Wisconsin, Dept of Psychiatry, Madison,  Wisconsin,  53719,  United States

      Northbrooke Research Center, Brown Deer,  Wisconsin,  53223,  United States

More Information

Study ID Numbers:  0600B-100469
Record last reviewed:  November 2002
Last Updated:  October 13, 2004
Record first received:  September 18, 2002
ClinicalTrials.gov Identifier:  NCT00046020
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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