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Venlafaxine extended-release effective for patients with major depression

December 12, 2007

Philadelphia, PA, December 12, 2007 - Major depressive disorder (MDD) is the most common major mental illness, afflicting almost one in five individuals. More than 75% of people who recover from an episode of MDD will have at least one recurrence, with the majority having multiple recurrences. MDD is the leading cause of disability of all medical illnesses, with substantial functional impairment, morbidity, and mortality. Few studies have assessed the efficacy of antidepressant medications beyond 1 year of maintenance treatment for the prevention of recurrent depression. However, a new study being published in the upcoming December 15th issue of Biological Psychiatry has done just that.

The PREVENT study, an acronym for the title of the study "The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years study," is, according to one of the senior authors on the paper, Dr. Martin B. Keller, "a multiphase, double-blind, randomized clinical trial designed to investigate the efficacy of the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine extended release in the prevention of depressive recurrence over 2 years in patients with a history of recurrent MDD who have responded to acute and continuation treatment." The investigators randomly assigned patients with recurrent depression to receive treatment with either venlafaxine extended-release (ER) or fluoxetine, an antidepressant already established as efficacious as a comparative medication. Although the PREVENT study followed patients for over two years, this article reports only on the acute and continuation phases, which were 10 weeks and 6 months long respectively.

Dr. Keller notes that this study "has several novel aspects to its design and methods," including its very large sample size, and long period of blinded treatment, where neither the physicians nor patients knew which medication the patient was receiving. The authors found that nearly 80% of the patients achieved at least an adequate therapeutic response to acute phase treatment with venlafaxine ER or fluoxetine, and almost none of the responders who continued on treatment for 6 months relapsed.

Husseini K. Manji, M.D., FRCP(C), Deputy Editor of Biological Psychiatry and Director of the Mood and Anxiety Disorders Program at the National Institute of Mental Health, comments on the study's findings:

"Major depression is a serious, debilitating, life-shortening illness that affects millions of people worldwide. This is thus an important study that shows surprisingly high response and remission rates. For many patients, major depression is a chronic illness characterized by multiple episodes of symptom exacerbation, residual symptoms between episodes, and functional impairment. Thus, the ability to maintain patients in remission is critical to reducing long-term disability."

In addition to the high response rates by the patients in this study, the rates of adverse events (side effects) were similar among the two treatment groups. Dr. Manji does issue a caution though with regard to generalizing the findings, noting that "the investigators studied a group of patients whose course of illness was not chronic. Furthermore, they excluded patients with a history of treatment resistance or significant comorbid illnesses." However, he added that "if replicated, the results suggest that there may be a subgroup of depressed patients for whom early and sustained treatment can maintain response and prevent relapses." Dr. Keller remarks that these results are "critical to clinical practice and should be considered when choosing a treatment for patients with recurrent MDD."
-end-
Notes to Editors:

The article is "The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) Study: Outcomes from the Acute and Continuation Phases" by Martin B. Keller, Madhukar H. Trivedi, Michael E. Thase, Richard C. Shelton, Susan G. Kornstein, Charles B. Nemeroff, Edward S. Friedman, Alan J. Gelenberg, James H. Kocsis, David L. Dunner, Boadie W. Dunlop, Robert M. Hirschfeld, Anthony J. Rothschild, James M. Ferguson, Alan F. Schatzberg, John M. Zajecka, Ron Pedersen, Bing Yan, Saeeduddin Ahmed, Michael Schmidt and Philip T. Ninan. Dr. Keller is with Brown University in Providence, Rhode Island. Dr. Trivedi is with the University of Texas Southwestern Medical School in Dallas, Texas. Drs. Thase and Friedman are with the University of Pittsburgh School of Medicine in Pittsburgh, Pennsylvania. Dr. Shelton is with Vanderbilt University in Nashville, Tennessee. Dr. Kornstein is with Virginia Commonwealth University in Richmond, Virginia. Drs. Nemeroff and Dunlop are with Emory University School of Medicine in Atlanta, Georgia. Dr. Gelenberg is with the University of Arizona in Tucson, Arizona. Dr. Kocsis is with Weill Cornell Medical College in New York, New York. Dr. Dunner is with the Center for Anxiety and Depression in Mercer Island, Washington. Dr. Hirschfeld is with the University of Texas Medical Branch in Galveston, Texas. Dr. Rothschild is with the University of Massachusetts Medical School and UMass Memorial Health Care in Worcester, Massachusetts. Dr. Ferguson is with the University of Utah in Salt Lake City, Utah. Dr. Schatzberg is with Stanford University School of Medicine, Stanford, California. Dr. Zajecka is with Rush University Medical Center, Chicago, Illinois. Drs. Pedersen, Yan, Ahmed, Schmidt, and Ninan are affiliated with Wyeth Research in Collegeville, Pennsylvania. The article appears in Biological Psychiatry, Volume 62, Issue 12 (December 15, 2007), published by Elsevier.

Full text of the article mentioned above is available upon request. Contact Jayne M. Dawkins at (215) 239-3674 or ja.dawkins@elsevier.com to obtain a copy or to schedule an interview.

About Biological Psychiatry

This international rapid-publication journal is the official journal of the Society of Biological Psychiatry. It covers a broad range of topics in psychiatric neuroscience and therapeutics. Both basic and clinical contributions are encouraged from all disciplines and research areas relevant to the pathophysiology and treatment of major neuropsychiatric disorders. Full-length and Brief Reports of novel results, Commentaries, Case Studies of unusual significance, and Correspondence and Comments judged to be of high impact to the field are published, particularly those addressing genetic and environmental risk factors, neural circuitry and neurochemistry, and important new therapeutic approaches. Concise Reviews and Editorials that focus on topics of current research and interest are also published rapidly.

Biological Psychiatry (www.sobp.org/journal) is ranked 4th out of the 95 Psychiatry titles and 16th out of 199 Neurosciences titles on the 2006 ISI Journal Citations Reports® published by Thomson Scientific.

About Elsevier

Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health communities, Elsevier's 7,000 employees in over 70 offices worldwide publish more than 2,000 journals and 1,900 new books per year, in addition to offering a suite of innovative electronic products, such as ScienceDirect (http://www.sciencedirect.com/), MD Consult (http://www.mdconsult.com/), Scopus (http://www.info.scopus.com/), bibliographic databases, and online reference works.

Elsevier (http://www.elsevier.com/) is a global business headquartered in Amsterdam, The Netherlands and has offices worldwide. Elsevier is part of Reed Elsevier Group plc (http://www.reedelsevier.com/), a world-leading publisher and information provider. Operating in the science and medical, legal, education and business-to-business sectors, Reed Elsevier provides high-quality and flexible information solutions to users, with increasing emphasis on the Internet as a means of delivery. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).

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