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NCT00285766 Clinical Trial

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

Major Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00285766
Other study ID # S9303-P0204
Secondary ID
Status Completed
Phase Phase 3
First received January 31, 2006
Last updated April 21, 2008
Start date August 2002
Est. completion date July 2005

Study information
Verified date April 2008
Source Somerset Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility - 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Selegiline Transdermal System

Locations
Country Name City State
United States Robert Riesenberg, M.D. Atlanta Georgia
United States Mitchel Kling, M.D. Baltimore Maryland
United States Abbey Strauss, M.D. Boynton Beach Florida
United States Mohammed Bari, M.D. Chula Vista California
United States James Hartford, M.D. Florence Kentucky
United States Barry Baumel, M.D. Miami Beach Florida
United States Louise Beckett, M.D. Oklahoma City Oklahoma
United States Charles Meredith, M.D. San Diego California
United States Margarita Nunez, M.D. St. Petersburg Florida
United States Mildred Farmer, M.D. St. Petersburg Florida
United States Larry Eisner, M.D. Tamarack Florida
United States Daniel Zimbroff, M.D. Upland California
United States Kathleen Toups, M.D. Walnut Creek California
United States Penny Barnhart, M.D. Wichita Falls Texas
United States Andrew Cutler, M.D. Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Somerset Pharmaceuticals

Country where clinical trial is conducted

United States, 

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