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

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

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

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