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Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285766
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : April 22, 2008
Information provided by:
Somerset Pharmaceuticals

Brief Summary:
Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Selegiline Transdermal System Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression
Study Start Date : August 2002
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Men/Women in good health 65 years or older
  • Ability to read, understand and sign study informed consent
  • Major depression- mild to severe based on rating scale

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285766

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United States, California
Mohammed Bari, M.D.
Chula Vista, California, United States, 91910
Charles Meredith, M.D.
San Diego, California, United States, 92108
Daniel Zimbroff, M.D.
Upland, California, United States, 94589
Kathleen Toups, M.D.
Walnut Creek, California, United States, 94589
United States, Florida
Abbey Strauss, M.D.
Boynton Beach, Florida, United States, 33437
Barry Baumel, M.D.
Miami Beach, Florida, United States, 33154
Margarita Nunez, M.D.
St. Petersburg, Florida, United States, 33702
Mildred Farmer, M.D.
St. Petersburg, Florida, United States, 33710
Larry Eisner, M.D.
Tamarack, Florida, United States, 33321
Andrew Cutler, M.D.
Winter Park, Florida, United States, 32789
United States, Georgia
Robert Riesenberg, M.D.
Atlanta, Georgia, United States, 30308
United States, Kentucky
James Hartford, M.D.
Florence, Kentucky, United States, 41042
United States, Maryland
Mitchel Kling, M.D.
Baltimore, Maryland, United States, 21201
United States, Oklahoma
Louise Beckett, M.D.
Oklahoma City, Oklahoma, United States, 73103
United States, Texas
Penny Barnhart, M.D.
Wichita Falls, Texas, United States, 76309
Sponsors and Collaborators
Somerset Pharmaceuticals
Layout table for additonal information Identifier: NCT00285766    
Other Study ID Numbers: S9303-P0204
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008
Keywords provided by Somerset Pharmaceuticals:
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs