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

This study has been completed.
Sponsor:
Information provided by:
Somerset Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00285766
First received: January 31, 2006
Last updated: April 21, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Major Depression
Drug: Selegiline Transdermal System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Somerset Pharmaceuticals:

Estimated Enrollment: 300
Study Start Date: August 2002
Estimated Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285766

Locations
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
Mildred Farmer, M.D.
St. Petersburg, Florida, United States, 33710
Margarita Nunez, M.D.
St. Petersburg, Florida, United States, 33702
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00285766     History of Changes
Other Study ID Numbers: S9303-P0204
Study First Received: January 31, 2006
Last Updated: April 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Somerset Pharmaceuticals:
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Selegiline
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on July 20, 2014